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LEGAL ACTS OF THE REPUBLIC OF LATVIA
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The translation of this document is outdated.
Translation validity: 29.09.2010.–30.06.2012.
Amendments not included: 19.06.2012., 19.08.2014.
Text consolidated by Valsts valodas centrs (State Language Centre) with amending regulations of:

22 July 2008;
31 March 2009;
13 October 2009;
21 September 2010.

If a whole or part of a paragraph has been amended, the date of the amending regulation appears in square brackets at the end of the paragraph. If a whole paragraph or sub-paragraph has been deleted, the date of the deletion appears in square brackets beside the deleted paragraph or sub-paragraph.


Republic of Latvia

Cabinet
Regulation No. 581
Adopted 2 August 2005

Procedures for Registration, Conformity Assessment, Distribution, Operation and Technical Supervision of Medical Devices

Issued pursuant to Section 34, Paragraph one of the Medical Treatment Law and
Section 7, Paragraphs one and two of the Law On Conformity Assessment

[21 September 2010]

1. General Provisions

1. This Regulation prescribes the procedures for the performance of registration, conformity assessment of medical devices, as well as for the distribution, operation and technical supervision thereof.

[22 July 2008]

2. The State Agency of Medicines (hereinafter - Agency) shall be the authority competent regarding registration and conformity assessment of medical devices. Manufacture, distribution, operation and technical supervision of medical devices shall be performed by the Health Inspectorate (hereinafter - Inspectorate).

[13 October 2009]

3. The conformity of medical devices shall be assessed by conformity assessment bodies which have been registered in compliance with the requirements referred to in Chapter 12.1 of this Regulation and regarding which the Ministry of Economics has published an announcement in the newspaper Latvijas Vēstnesis [the official Gazette of the Government of the Republic of Latvia] (hereinafter - notified bodies). The notified bodies shall be:

3.1. conformity assessment bodies which have been accredited in the limited liability company "Standardisation, Accreditation and Metrology Centre" in compliance with the requirements of the following standards:

3.1.1. LVS EN ISO/IEC 17020:2005 "General criteria for the operation of various types of bodies performing inspection", in order to assess the conformity in accordance with the procedure referred to in Annex 7 to this Regulation;

3.1.2. LVS EN 45011:2004 "General requirements for bodies operating product certification systems", in order to assess the conformity in accordance with the procedure referred to in Annexes 6, 7, 13, 14 and 18 to this Regulation;

3.1.3. LVS EN ISO/IEC 17021:2007 "Conformity assessment - Requirements for bodies providing audit and certification of management systems", in order to assess the conformity in accordance with the procedure referred to in Annexes 5, 8, 9, 10, 12, 13, 17, 19 and 20 to this Regulation;

3.2. notified bodies of other European Union Member States or European Economic Area States which comply with the standards of the referred to states in which the relevant harmonised standards have been adopted.

[31 March 2009; 13 October 2009]

3.1 The personnel (including at least one person recommended by the Latvian Association of Infectologists), which has theoretical and professional knowledge regarding transfer risk of transmissible spongiform encephalopathy (TSE) to a patient or other persons using medical devices which have been manufactured utilising animal tissues which have been rendered non-viable or products of the origin of such tissues (hereinafter - tissue medical devices) in compliance with the functions intended for them, shall be at the disposal of the notified body.

[22 July 2008]

4. Medical devices (except in vitro diagnostic medical devices) shall be divided into the following Classes: I, IIa, IIb and III. Medical devices shall be classified in accordance with Annex 1 to this Regulation. In vitro diagnostic medical devices (hereinafter - in vitro diagnostic devices) shall be divided in devices of List A, devices of List B, devices for self-testing, other (rest) devices and devices for performance evaluation in accordance with Annex 2 to this Regulation. In case of discrepancies regarding application of classification provisions, the issue shall be decided by the Agency, applying the following information additionally:

4.1. the generic group of medical devices which is an aggregate of devices with equal or similar purpose of use or uniform technology that allows to classify them generally, without specifying particular specifications; and

4.2. the sub-category of devices which is an aggregate of devices with common purpose of use or common technology.

[31 March 2009]

5. In order to place medical devices on the market, an EC declaration of conformity shall be drawn up and they shall be marked with the CE marking (hereinafter - CE marking) (Annex 3). This provision shall not apply to medical devices:

5.1. which are custom-made;

5.2. which are medical devices intended for clinical investigations;

5.3. which are in vitro diagnostic medical devices for performance evaluation;

5.4. which fail to comply with the requirements specified in this Regulation; or

5.5. for which the necessary conformity assessment procedures have not been performed.

6. The CE marking shall be visible, legible and indelible, placed on the medical device, or on the sterile or sales packaging thereof in easily accessible and visible place, as well as on the instructions for use.

7. Identification number of the notified body involved in the conformity assessment assigned by the European Commission shall be indicated together with the CE marking for Class 1 sterile medical devices and medical devices with a measuring function, Class IIa, Class IIb and Class III medical devices, active implantable medical devices, medical devices of List A, List B and in vitro diagnostic medical devices for self-testing.

[22 July 2008]

8. Any other mark may be affixed to the medical device, to the sterile or sales packaging, as well as on the instruction for use provided that the visibility and legibility of the CE marking is not thereby reduced. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking.

9. Medical devices, which comply with the European harmonised standards adapted in the status of the national standard of Latvia (hereinafter - applicable standards) the references to which have been published in the Official Journal of the European Union, or with the common technical specifications in relation to in vitro diagnostic devices, shall comply with the essential requirements. The Agency shall, on the basis of the opinions of the relevant Technical Standards Committee of the European Commission and decisions of the European Commission, recommend the limited liability company "Standardisation, Accreditation and Metrology Centre" the list of adaptable standards of the European Union. The limited liability company "Standardisation, Accreditation and Metrology Centre" shall submit for the publication in the newspaper Latvijas Vēstnesis the list of applicable standards adapted in the status of the national standard of Latvia which are applied for the fulfilment of the requirements of this Regulation.

[13 October 2009]

10. Within the meaning of this Regulation the publication referred to in Paragraph 9 of this Regulation shall also apply to the monographs of the European Pharmacopoeia, including to those on surgical sutures, as well as on interaction between medicinal products and materials used in medical devices containing such medicinal products and the references of which have been published in the Official Journal of the European Union.

11. Structure, operation and safety of custom-made medical devices may be determined not only by a medical practitioner, but also by any person who has appropriate professional qualification.

12. Custom-made medical device means medical device made in accordance with instructions of medical practitioners and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements determined by the medical practitioners or any other professional users are not considered to be custom-made medical devices.

13. The obligations determined in this Regulation to be met by a manufacturer of medical devices also apply to such persons who assemble, package, process, refurbish or label one or more ready-made medical devices and assign to them their intended purpose as a medical device with a view to their being placed on the market. This condition shall not apply to the persons who assemble or adapt devices already on the market for an individual patient.

14. Where a medical device is intended to administer a medicinal product registered in the Register of Medicinal Products of the Republic of Latvia, this Regulation shall apply thereto.

15. [13 October 2009]

16. This Regulation shall not be applied in relation to:

16.1. medicinal products, also to medicinal products, products or derivatives obtained from human blood and plasma, from live cells and tissues of human origin, as well as to transplants of human origin;

16.2. human blood, blood products, plasma or blood cells of human origin and to medical devices which incorporate such blood products, plasma or cells at the time of placing on the market, except the medical devices referred to in Paragraph 15 of this Regulation;

16.3. cosmetic products;

16.4. individual (personal) protective equipment which are not used in the health care;

16.5. medical devices which are placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended for single use and exclusively for use in the given combination and which is not reusable; and

16.6. the requirements for protection against harmful impact of ionizing radiation (also in relation to irradiation of a person related to diagnostics or treatment of the disease) determined in regulatory enactments.

[31 March 2009]

17. Essential requirements in relation to the operation and safety of medical devices included in this Regulation shall apply to the devices referred to in Sub-paragraph 16.5 of this Regulation and they shall be registered by the Agency.

[13 October 2009]

18. In deciding whether a medical device falls under this Regulation, the purpose for which the particular medical device is manufactured and intended shall be taken into account.

19. The information, which is available to the user and the patient so that they could use a medical device in compliance with the intended purpose thereof, shall be in the official language, unless it is provided otherwise in this Regulation.

20. A medical device may be placed on the market only if all essential requirements determined by this Regulation are fulfilled and the conformity assessment procedure is performed at the notified body (for the medical devices referred to in Paragraph 7 of this Regulation). A manufacturer or the authorised representative thereof shall, in accordance with the notification procedure, send the Agency (by post or electronically to the official electronic mail address of the Agency) the information (notification) regarding manufacturer of the device and certifications of the conformity assessment procedures of the device (declaration of conformity and CE certificate) in relation to the placing on the market of Class IIb and Class III medical devices and medical devices of List A, List B and in vitro diagnostic medical devices for self-testing in the territory of the Republic of Latvia. The information (notification) shall be prepared in accordance with the sample (Annex 3.1) published on the Internet homepage of the Agency (www.zva.gov.lv). The Agency has no right to request additional information and fee for notification from the manufacturer or the authorised representative thereof.

[13 October 2009]

20.1 In order to place Class I and Class IIa medical devices on the market in the territory of the Republic of Latvia, they shall be labelled with CE marking. It is not necessary to notify regarding Class I and Class IIa medical devices and other (rest) in vitro diagnostic devices.

[31 March 2009]

21. [22 July 2008]

2. Essential Requirements to be Determined for Medical Devices

2.1. General Requirements

22. This Chapter shall specify the essential requirements to be determined for medical devices in relation to the structure, operation and safety thereof. Medical device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. Accessories, which whilst not being medical devices are intended specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device, within the meaning of this Regulation shall be considered as medical devices.

23. The provisions of this Chapter shall not apply to active implantable medical devices and in vitro diagnostic devices.

24. Medical devices shall be designed and manufactured in such a way that, when used for the purposes intended in compliance with the instructions for use specified by a manufacturer, they will not cause damage to the health and life of patients, users and third persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety providing that:

24.1. ergonomic parameters and the environment where it is intended to use the device are taken into account reducing the user error risk as much as possible (patient safe design);

24.2. technical knowledge, experience, education, training and in the relevant case - also medicinal and physical condition of expected users (designs for non-professional users, professional users, disabled persons and other users) is taken into account.

[31 March 2009]

24.1 If a medical device is also machinery within the meaning of the regulatory enactments regarding safety of machinery, not only the requirements referred to in Sub-chapter 2.2 of this Regulation, but also the essential requirements specified for the safety of machinery and risk analysis shall be applied thereto.

[31 March 2009]

25. Risk associated with the use of a medical device shall be commensurate with the benefit to the patient.

26. The solutions adopted by the manufacturer for the design and construction of medical devices shall conform with the operation and safety principles of medical devices, which are based on the state of the art of the relevant sector.

27. In selecting solutions for the design and construction of medical devices, the manufacturer shall observe the following principles:

27.1. reduce use risk;

27.2. take adequate protection measures;

27.3. use alarms in relation to risks that cannot be eliminated;

27.4. inform the user regarding any shortcomings of the protection measures which cause the residual risks.

28. The fulfilment of requirements referred to in Paragraphs 24, 25, 26 and 27 of this Regulation shall not be adversely affected to such a degree that the health or life of the patient, user or third person is compromised during the lifetime of the medical device as indicated by the manufacturer, when the medical device is subjected to the stresses which can occur during normal conditions of use.

29. The medical devices shall be designed, manufactured and packed in such a way that the performance and safety parameters during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer.

30. Any undesirable side-effect caused by use of medical device shall constitute an acceptable risk when weighed against the performance result intended.

2.2. Requirements to be Determined for Design and Construction

31. The following shall be observed in relation to chemical, physical and biological properties of medical devices:

31.1. the toxicity and flammability of materials used:

31.1.1. reducing, as much as possible, the risk caused by the presence of carcinogens, mutagens or substances toxic to reproduction in the device;

31.1.2. specifically reducing or specifically labelling the devices in the construction of which the filtrates, which have been classified as toxic substances referred to in Sub-paragraph 31.1.1 of this Regulation, have been used;

31.2. the compatibility between the materials used and biological tissues, cells and body fluids;

31.3. the medical devices do not subject a user, patient and third person involved in the transport, storage and use thereof to risk posed by contaminants and residues caused by the medical device;

31.4. the duration and frequency of exposure of tissues;

31.5. the medical devices may be used with the materials, substances and gases with which they enter into contact during their normal use or during routine procedures;

31.6. the medical devices intended for administration of medicinal products are designed and manufactured in such a way as to be compatible with the medicinal products concerned;

31.7. in case where a medical device incorporates, as an integral part, human blood derivative, the scientific opinion of the European Agency for the Evaluation of Medicinal Product (EMEA) regarding the quality and safety of the particular derivative is taken into account;

31.8. at least one sample from each series of intermediate product and final batch product of human blood derivative is examined in a laboratory selected for that purpose by the State; and

31.9. the risks posed by substances leaking from the medical device, as well as ingress of substances into the device are reduced as much as possible.

[31 March 2009]

32. In relation to infection and microbial contamination it shall be observed that:

32.1. the medical devices and manufacturing processes are designed in such a way as to reduce as far as possible the risk of infection to the patient, user and third parties;

32.2. the design of the medical device minimizes as far as possible the risk to infect the device by the patient or vice versa during use thereof;

32.3. tissues of animal origin originate from animals that have been subjected to veterinary controls;

32.4. the Agency and medical treatment institutions retain information on the geographical origin of the animals;

32.5. handling of tissues, cells and substances of animal origin is carried out so as to provide safety with regard to viruses and other transferable agents by implementation of methods validated in the European Union for elimination or viral inactivation in the course of the manufacturing process;

32.6. medical devices placed on the market in a sterile state are designed, manufactured and packed in a sales pack to ensure that the medical devices are sterile, observing the storage and transport conditions laid down, until the packaging is damaged or opened;

32.7. medical devices placed on the market in a sterile state are manufactured and sterilized in accordance with methods recognised and validated in the European Union, which have been specified in the applicable standards;

32.8. medical devices intended to be sterilized are manufactured in such environmental and hygienic conditions which ensure sterility of the medical device;

32.9. sales packaging for non-sterile medical devices ensures the storage of the medical device so as the medical device is not affected by the factors of external environment;

32.10. if the medical devices referred to in Sub-paragraph 32.9 of this Regulation are sterilised, the risk of infection caused by micro-organisms is minimized and packaging of medical device is suitable for the sterilisation method indicated by the manufacturer; and

32.11. the packaging or label of the medical device distinguishes between identical or similar medical devices sold in both sterile and non-sterile condition.

[22 July 2008]

33. In relation to the construction of medical devices, it shall be observed that:

33.1. if the medical device is intended for use in combination with other medical devices or equipment, the whole combination, including the connection system, is safe and does not impair the specified performances of the medical devices;

33.2. any restrictions on use are indicated in the instructions for use or on the label for the medical devices or the whole combination referred to in Sub-paragraph 33.1 of this Regulation;

33.3. medical devices are designed and manufactured in such a way as to remove or minimize as far as is possible:

33.3.1. the risk of injury, in connection with physical features of medical devices, including the volume and pressure ratio, dimensions and ergonomics of the medical device;

33.3.2. risks connected with magnetic fields, external electrical influences, electrostatic discharge, pressure, temperature and other conditions of external environment;

33.3.3. the risks of reciprocal interference with other medical devices normally used for the treatment or in the investigations;

33.3.4. risks arising where maintenance or calibration is not possible, from ageing of materials used or loss of accuracy of any measuring or control mechanism;

33.4. medical devices are designed and manufactured in such a way as to minimize the risks of fire or explosion using a medical device in compliance with the instructions for use of the manufacturer and in case of damage of the medical device.

33.1 For medical devices which incorporate software or which are medical software in themselves, the software shall be validated according to the state of the art, taking into account the principles of development lifecycle, risk management, validation and verification.

[31 March 2009]

34. During designing and manufacture process a manufacturer shall pay particular attention to medical devices whose intended use includes exposure to flammable substances.

35. For medical devices with a measuring function it shall be observed:

35.1. that such medical devices are designed and manufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of accuracy, especially taking account of the intended purpose of the device;

35.2. that the limits of accuracy are indicated in the instructions for use;

35.3. that the measurement, monitoring and display scale are designed in line with ergonomic principles, especially taking account of the intended purpose of the medical device; and

35.4. that the measurements made by such devices are expressed in units of measurement conforming to the standards applicable in the European Union or the Republic of Latvia.

36. For the protection against radiation it shall be observed that:

36.1. medical devices are designed and manufactured in such a way that exposure of patients, users and third persons to ionising radiation is reduced as far as possible, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes;

36.2. where devices are designed to emit hazardous levels of ionising radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it shall be possible for the user to control the emissions;

36.3. the medical devices referred to in Sub-paragraph 36.2 of this Regulation are designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters;

36.4. the medical devices, which are intended to emit potentially hazardous, visible or invisible ionising radiation, are fitted with visual displays or audible warnings of such emissions;

36.5. medical devices are designed and manufactured in such a way that exposure of patients, users and third persons to the emission of unintended, stray or scattered ionising radiation is reduced as far as possible;

36.6. detailed information is given in the instructions for use for medical devices emitting ionising radiation as to the nature of the emitted ionising radiation, means of protecting the patient, the user and third person, as well as on ways of avoiding misuse of such medical devices and of eliminating the risks inherent in installation of such medical device;

36.7. medical devices intended to emit ionising radiation are designed and manufactured in such a way as to ensure that, where practicable, the quantity, geometry and quality of ionising radiation emitted can be controlled and varied, especially taking into account the intended use of such medical device;

36.8. medical devices emitting ionising radiation intended for diagnostic radiology are designed and manufactured in such a way as to achieve appropriate image or output quality for the intended medical purpose whilst minimizing ionising radiation exposure of the patients, users and third persons; and

36.9. medical devices emitting ionising radiation, intended for therapeutic radiology are designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type, energy and the quality of ionising radiation.

[31 March 2009]

37. For medical devices connected to or equipped with an energy source it shall be observed that:

37.1. medical devices incorporating electronic programmable systems are designed to ensure the repeatability, reliability and performance of these systems according to the intended use;

37.2. in the event of damage of electronic programmable system appropriate means are adopted to eliminate consequent risks;

37.3. medical devices where the safety of the patients depends on an internal power supply are equipped with a means of determining the state of the power supply;

37.4. medical devices where the safety of the patients depends on an external power supply are equipped with an alarm system to signal any power failure;

37.5. medical devices intended to monitor one or more clinical parameters of a patient are equipped with alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health;

37.6. medical devices are designed and manufactured in such a way as to minimize the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment;

37.7. medical devices are designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks using them in compliance with instructions of the manufacturer and in case of insignificant damage;

37.8. medical devices are designed and manufactured protecting the patients, users and third persons against mechanical risks caused by resistance, instability of the medical devices and moving parts thereof;

37.9. medical devices are designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration and noise generated by the medical device, especially taking account of technical progress and of the means available for limiting vibrations and noise (except the cases where the vibrations or noise are part of the specified performance of the medical device);

37.10. terminals and connectors to the electricity, hydraulic and pneumatic energy supplies are designed and manufactured in such a way as to reduce, as far as possible, the risks which may be caused by them to the health and life of users of the medical device using the medical devices in compliance with the instructions for use of the manufacturer;

37.11. parts of the medical devices which come into contact with a user, patient or third person during the use (excluding the parts intended to supply heat or reach given temperatures) do not attain temperatures specified in the instructions of the manufacturer, if the medical device is used in compliance with the instructions for use of the manufacturer;

37.12. medical devices, in which energy and substances are used, are designed and constructed providing the possibility to set and maintain the flow-rate of energy or substance accurately thus guaranteeing the safety of the patient, user and of the third persons;

37.13. medical devices are fitted with the equipment which prevents any dangerous inadequacy in the flow-rate of energy or substances or indicates thereon;

37.14. medical devices are fitted with equipment which prevents the accidental release of dangerous levels of energy or substance from an energy or substance source;

37.15. the function of the controls and indicators are specified on the medical devices; and

37.16. where a medical device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information is clearly understandable to the user and, as appropriate, the patient and third persons.

38. The manufacturer shall provide the information to users of medical devices, patients and third persons regarding:

38.1. the name and address of the manufacturer or an authorised representative thereof registered in the European Union;

38.2. safe use of the medical device, especially taking account of the knowledge and training of the potential users (such information shall be included in the instructions for use of the medical device or placed on the label of the medical device).

[31 March 2009]

39. The information regarding safe use of medical devices shall be set out on the device itself or on the packaging for each unit or on the sales packaging. If individual packaging of each medical device is not practicable, the referred to information shall be attached to several medical devices by means of leaflet or otherwise, taking into account the purpose of provision of such information.

40. Instructions for use shall be included in the packaging for every medical device, except the case referred to in Paragraph 39 of this Regulation. Instructions for use shall not be necessary for medical devices in Class I or IIa if non-professional purpose, for which the medical device is intended, is clear without any such instructions.

41. The information included in the instructions for use may be in the form of paper or electronic form and may consist of symbols, if they (as well as the identification colours used) comply with the applicable standards recognised in the Republic of Latvia and the European Union.

[31 March 2009]

42. If there are no applicable standards in the area related to medical devices, the symbols and colours shall be described in the instructions for use of the medical device or in other documentation supplied with the medical device.

43. The label of the medical device shall bear the following particulars:

43.1. the name and address of the manufacturer;

43.2. the information regarding properties and functions of the medical device;

43.3. the word "STERILE", if the medical device is sterile;

43.4. the batch code of medical devices assigned by the manufacturer and preceded by the word "LOT", or the serial number assigned by the manufacturer;

43.5. the term of validity of the device specifying the year and month until which the medical device may be used safely, if the medical device has limited time of use (or the lifetime resource of the device, if the medical device has limited lifetime resource);

43.6. an indication that the medical device is intended for single use for one patient;

43.7. if the medical device is custom-made, the words "custom-made device";

43.8. [21 September 2010];

43.9. any special storage or handling conditions;

43.10. any special operating instructions;

43.11. any essential warnings or precautions to take;

43.12. year of manufacture for those medical devices to which Sub-paragraph 43.5 of this Regulation does not apply (it may be included in the batch or serial number);

43.13. the method of sterilization; and

43.14. indication whether the medical device contains derivative of human blood, cells or tissues of human origin.

[22 July 2008; 31 March 2009]

44. If the intended purpose of the medical device is not obvious to the non-professional, the manufacturer shall clearly state it on the label and in the instructions for use.

45. If absolute compatibility and interoperability of the components (complementary parts) is ensured, the medical devices and detachable components (complementary parts) thereof shall be identified with the batch or serial number assigned by the manufacturer reducing the risk posed by the use of the medical devices and detachable components thereof.

46. If the relevant information cannot be included on the label of the medical device, the instructions for use of the medical device shall contain the following particulars:

46.1. the information referred to in Paragraph 43 of this Regulation;

46.2. the characteristics and functions of the medical device, as well as undesirable side-effects caused by the use thereof;

46.3. the information regarding parameters of the medical device, if the medical device is to be installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose;

46.4. the information needed to verify whether the medical device is properly installed and can operate in compliance with the instructions determined by the manufacturer, as well as the information regarding its maintenance and calibration;

46.5. information to avoid certain risks in connection with implantation of the medical device;

46.6. information regarding the risks of reciprocal interference posed by the presence of the medical device during specific investigations or treatment;

46.7. the instructions in the event of damage to the sterile packaging of medical device which retains sterility of the medical device, as well as regarding appropriate methods of resterilisation for a particular medical device;

46.8. information on the appropriate processes, if the medical device is reusable - how to clean, disinfect, pack or resterilise it, as well as the information regarding restrictions in relation to the number of reuses;

46.9. the instructions how to clean and sterilise the medical device, if it is intended to sterilise it before use in accordance with the instructions of the manufacturer;

46.10. the instructions regarding special handling needed before the medical device can be used;

46.11. details of the nature, type, intensity and distribution of the ionising radiation, if the medical device is intended for emitting ionising radiation for medical purposes;

46.12. the information on any possible contra-indications;

46.13. the details on any precautions to be taken in particular:

46.13.1. precautions to be taken in the event of changes in the performance of the medical device;

46.13.2. precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources and other influence;

46.13.3. adequate information regarding the medicinal products which the medical device in question is designed to administer, as well as any limitations in the choice of substances to be delivered;

46.13.4. precautions to be taken against any risks related to the disposal of the medical device;

46.13.5. medicinal substances incorporated into the medical device as an integral part in accordance with Paragraph 15 of this Regulation;

46.13.6. degree of accuracy of medical devices with a measuring function.

[31 March 2009]

47. Where conformity with the essential requirements is based on clinical data, such data shall be established in accordance with the regulatory enactments regulating the procedures for clinical investigations of medical devices intended for humans.

[21 September 2010]

47.1 [21 September 2010]

3. Essential Requirements to be Determined for Active Implantable Medical Devices

3.1. General Requirements

48. This Chapter specifies the essential requirements to be determined for active implantable medical devices in relation to the structure, operation and safety thereof. Active implantable medical device means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after such procedure.

49. Active implantable medical devices shall be designed and manufactured in such a way that, when implanted in compliance with the instructions specified by the manufacturer and for the purpose intended for the device, their use does not compromise the clinical condition or the safety of patients. Active implantable medical devices shall not present any risk to the persons implanting them, as well as to the third persons.

50. The characteristics and performances referred to in Paragraph 49 of this Regulation shall not be adversely affected to such a degree that the clinical condition and safety of the patients or of other persons are compromised during the lifetime of the device anticipated by the manufacturer, where the active implantable device is subjected to stresses which may occur during normal conditions of use.

51. The active implantable medical devices shall be designed, manufactured and packed, as well as stored and transported in compliance with the storage and transport conditions specified by the manufacturer not reducing the efficiency of use of the active implantable medical device.

52. Any side effects caused by active implantable medical device shall be outweighed to the benefit provided by it to a patient.

3.2. Requirements to be Determined for Design and Construction

53. The solutions for the design and construction of the active implantable medical devices which are used by the manufacturer shall comply with safety principles which contain state of the art of the relevant sector.

54. Active implantable medical devices shall be designed, manufactured and packed in a sales pack ensuring that they are sterile when placed on the market and, taking into account the storage and transport conditions specified by the manufacturer, remain so until the packaging is removed and they are implanted.

55. Active implantable medical devices shall be designed and manufactured in such a way as to remove or minimize as far as possible:

55.1. the risk of injury to active implantable medical device in connection with its physical (including dimensional) features;

55.2. risks connected with the use of energy sources with insufficient insulation, leakage currents and overheating of the active implantable medical device;

55.3. possible risks connected with magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure and acceleration, as well as other foreseeable environmental conditions;

55.4. possible risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment;

55.5. possible risks connected with ionizing radiation from radioactive substances included in the active implantable medical device;

55.6. risks which may arise where maintenance and calibration of the active implantable medical device are impossible, including:

55.6.1. excessive increase of leakage currents;

55.6.2. ageing of the materials used;

55.6.3. excess heat generated by the medical device; and

55.6.4. decreased accuracy of any measuring or control mechanism of medical devices with measuring function.

[31 March 2009]

56. For the designing and manufacture of the active implantable medical devices the following shall be observed:

56.1. the materials used and toxicity thereof;

56.2. mutual compatibility between the materials used and biological tissues, cells and body fluids, especially taking into account the functions of the active implantable medical device;

56.3. compatibility of the active implantable medical devices with the substances they are intended to dispense and administer;

56.4. the quality of the connections and sources of energy in respect of safety of the active implantable medical device;

56.5. that leakage is not possible from active implantable medical devices; and

56.6. proper functioning of the computer hardware and control systems.

57. The active implantable medical devices and, if appropriate, their component parts shall be identified to allow any necessary measure to be taken, if the active implantable medical device or component parts thereof endanger the health and life of a patient, user or third person.

58. Active implantable medical device shall bear a numerical code assigned by the Agency or other competent authority of the European Union Member State, notified body, or manufacturer by which it is possible to identify its manufacturer, type and year of manufacture. It shall be possible to read this numerical code without the need for a surgical operation.

[22 July 2008]

59. When an active implantable medical device, its component parts or accessories bear instructions for use or indications which indicate operating and adjustment parameters, such information shall be displayed in such a way as to be understandable to the user and the patient taking into account their level of preparedness and functions of the active implantable medical device.

60. Sterile packaging of every active implantable medical device shall bear, legibly and indelibly, the information (where appropriate in the form of recognized symbols which are included in the applicable standards) which includes the following:

60.1. the method of sterilization;

60.2. an indication permitting this packaging to be recognized as sterile;

60.3. the name and address of the manufacturer;

60.4. characterisation and functions of the active implantable medical device;

60.5. [21 September 2010];

60.6. if the active implantable medical device is custom-made, the words "custom-made device";

60.7. a labelling recognised in the European Union attesting that the active implantable medical device is in a sterile condition;

60.8. the year and month of manufacture of the active implantable medical device; and

60.9. the time limit for implanting an active implantable medical device safely.

61. Sales packaging of every active implantable medical device shall bear, legibly and indelibly, the information (where appropriate in the form of recognized symbols) which includes the following:

61.1. the name and address of the manufacturer;

61.2. characterisation and functions of the active implantable medical device;

61.3. essential parameters of use;

61.4. [21 September 2010];

61.5. if the active implantable medical device is custom-made, the words "custom-made device";

61.6. a labelling attesting that the active implantable medical device is in a sterile condition;

61.7. the year and month of manufacture of the active implantable medical device;

61.8. the time limit for implanting an active implantable medical device safely; and

61.9. the conditions for transporting and storing the active implantable medical device.

62. When placed on the market, each device shall be accompanied by instructions for use giving the following particulars:

62.1. indication regarding the year when the authorization to affix the CE mark to the active implantable medical device has been granted;

62.2. the details referred to in Paragraphs 60 and 61 of this Regulation (with the exception of those referred to in Sub-paragraphs 60.8 and 60.9);

62.3. the information on any possible side effects;

62.4. information allowing the physician to determine and select a suitable active implantable medical device, software and accessories;

62.5. the instructions for use for the physicians (in certain cases - also for the patient) on use of the active implantable medical devices, their accessories and software in compliance with the functions of a particular device;

62.6. information allowing certain risks in connection with implantation of the device to be avoided;

62.7. information regarding possible reciprocal interference (adverse effects on the active implantable medical device caused by instruments used at the time of investigation or treatment or the same effects on the referred to instruments caused by the active implantable medical device) which may be caused by the active implantable medical devices during a particular investigation or treatment;

62.8. the necessary instructions in the event of the sterile pack of the active implantable medical device being damaged and, where appropriate, details of appropriate methods of resterilisation;

62.9. an indication, if appropriate, regarding reuse of an active implantable medical device only if it is reconditioned and complies with the essential requirements referred to in this Chapter;

62.10. information regarding all possible contra-indications and the relevant precautions to be taken;

62.11. information regarding the lifetime of the energy source;

62.12. information regarding precautions to be taken should unforeseen changes are observed in the active implantable medical device's performance;

62.13. information regarding precautions to be taken, if the active implantable medical device is exposed to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in acceleration, as well as to other foreseeable environmental conditions; and

62.14. the necessary information regarding the medicinal products which the active implantable medical device in question is designed to administer.

4. Essential Requirements to be Determined for in Vitro Diagnostic Devices

4.1. General Requirements

63. This Chapter specifies essential requirements to be determined for in vitro diagnostic devices in relation to the structure, operation and safety thereof. In vitro diagnostic device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, equipment, or system, whether used alone or in combination with other medical devices and intended by the manufacturer to be used in vitro diagnostic in order to research specimens obtained from a human body, including blood and tissue donations, solely or principally for the purpose of obtaining of the information concerning his or her physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. Products for general laboratory use are not in vitro diagnostic devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination. Accessories are devices which are intended specifically by their manufacturer to be used together with a medical device used in vitro diagnostic to enable that device to be used in accordance with its intended purpose.

64. For the purposes of this Regulation, calibration and control materials, which are determined by the manufacturer for the relevant device, refer to any substance, material or article intended by their manufacturer to establish measurement relationships or to verify the performance characteristics of an in vitro diagnostic device in conjunction with the intended functions of that device.

65. The essential requirements in respect of in vitro diagnostic devices designed and manufactured in conformity with applicable (technical) standards drawn up for the in vitro diagnostic devices in List A of Annex 2 to this Regulation and, in exceptional cases provided for in this Regulation, the in vitro diagnostic devices in List B of Annex II are listed in this Chapter. Manufacturers shall observe the referred to standards, but in case they do not comply with those standards for duly justified reasons, they shall find a solution in such a way so as to maintain the safety level of in vitro diagnostic devices equivalent to the level specified in standards.

66. In vitro diagnostic devices shall be designed and manufactured in such a way that, when used in compliance with the instructions for use specified by a manufacturer, they will not cause damage to the health, life and property of patients, users and third persons. Risk to which a patient is exposed when using a particular in vitro diagnostic device shall be outweighed against the benefit to the patient.

67. The solutions adopted by the manufacturer for the design and construction of the in vitro diagnostic devices shall conform to safety principles, taking account of the generally acknowledged state of the art of the relevant sector.

68. In vitro diagnostic devices shall achieve the performances stated by the manufacturer (including in terms of analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, control of known relevant interference, and limits of detection). The traceability of values assigned to calibrators or control materials shall be assured through available reference measurement procedures or available control materials of a higher order.

69. If the in vitro diagnostic device is subjected to the stresses when using it under normal conditions of use, the performance and functions thereof shall not be adversely affected to such a degree that the health or life of the patient, the user or third persons are compromised during the lifetime of the device as indicated by the manufacturer. If lifetime is not stated by the manufacturer in accordance with this Regulation, the usual lifetime of in vitro diagnostic device of a particular kind shall be taken into account.

70. The in vitro diagnostic devices shall be designed and manufactured in such a way that performance and functions of in vitro diagnostic devices during their intended use will not be adversely affected under storage and transport conditions provided by the manufacturer.

4.2. Requirements to be Determined for Design and Construction

71. In respect of chemical and physical properties of in vitro diagnostic devices the following shall be observed:

71.1. that in vitro diagnostic devices are designed and manufactured ensuring their performance and functions in compliance with the provisions referred to in Sub-chapter 4.1 of this Regulation;

71.2. impairment of analytical performance due to incompatibility between the materials used and the specimens intended to be used with the in vitro diagnostic device, taking account of the purpose of acquisition thereof; and

71.3. that in vitro diagnostic devices are designed, manufactured and packed in such a way as to reduce as far as possible the risk posed by product leakage, contaminants and residues to the persons involved in the transport and storage or use of the devices.

72. In respect of infection and microbial contamination which may be caused by in vitro diagnostic devices it shall be observed that:

72.1. in vitro diagnostic devices and their manufacturing processes are designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patients, users or third persons;

72.2. the design of in vitro diagnostic device ensures easy handling thereof and, where necessary, reduces the possibility to contaminate or infect in vitro diagnostic device and the possibility of in vitro diagnostic device to infect a patient during use thereof (this provision applies also to specimen receptacles - in vitro diagnostic devices which may be also a kind of vacuum devices and which are intended for containing and storage of specimen acquired from a human body for the purpose of in vitro diagnostic investigation);

72.3. where in vitro diagnostic device incorporates biological substances, the risks of infection of a patient, user and third persons are reduced as far as possible by selecting appropriate donors and appropriate substances, as well as by using validated inactivation, conservation, test and control procedures;

72.4. in vitro diagnostic devices labelled as "STERILE" or in vitro diagnostic devices having a special microbiological state are designed, manufactured and processed in accordance with validated methods and packed in an appropriate pack, which would retain the special microbiological state indicated on the label of in vitro diagnostic devices when placed on the market, under the storage and transport conditions specified by the manufacturer, until the referred to packaging is damaged or opened;

72.5. packaging systems for in vitro diagnostic devices (other than those referred to in Sub-paragraph 72.4 of this Regulation) keep the product without deterioration at the level of cleanliness (the impact of the external environment factors) indicated by the manufacturer and, if in vitro diagnostic devices are to be sterilised prior to use, reduce as far as possible the risk of microbial contamination;

72.6. steps are taken to reduce as far as possible risk of microbial contamination during selection and handling of raw materials, manufacture, storage and distribution of in vitro diagnostic devices, if the performance of in vitro diagnostic device can be adversely affected by microbial contamination;

72.7. in vitro diagnostic devices intended to be sterilised are manufactured using validated control methods;

72.8. packaging systems for non-sterile in vitro diagnostic devices keep the product without deterioration at the level of cleanliness (the impact of external environment factors) stipulated by the manufacturer and, if the devices are to be sterilised prior to use, minimise the risk of microbial contamination;

72.9. the packaging system is suitable taking account of the method of sterilisation indicated by the manufacturer.

73. In respect of manufacturing conditions of in vitro diagnostic devices it shall be observed that:

73.1. if the in vitro device is intended for use in combination with other devices or equipment, the whole combination, including the connection system, is safe and does not impair the performances of in vitro diagnostic devices (any restrictions on use shall be indicated on the label or in the instructions for use);

73.2. in vitro diagnostic devices are designed and manufactured in such a way as to reduce as far as possible the risks linked to use of in vitro diagnostic devices in conjunction with materials, substances and gases with which they may come into contact using them in compliance with the intended functions;

73.3. in vitro diagnostic devices are designed and manufactured in such a way as to remove or reduce as far as possible the risk of in vitro diagnostic device to cause health damage due to their physical features (including size);

73.4. in vitro diagnostic devices are designed and manufactured in such a way as to remove or reduce as far as possible risk linked to magnetic fields, external electrical effects, electrostatic discharge, pressure, humidity, temperature or variations in pressure or acceleration or accidental penetration of substances into in vitro diagnostic device;

73.5. an adequate level of intrinsic immunity of electromagnetic disturbance is provided for in vitro diagnostic devices to retain performance of functions of in vitro diagnostic device;

73.6. the risks of fire or explosion of in vitro diagnostic devices during their use in compliance with the instructions for use of the manufacturer and in case of damage are reduced as far as possible for in vitro diagnostic devices;

73.7. in vitro diagnostic devices are designed and manufactured in such a way as to facilitate the management of safe waste disposal; and

73.8. the measuring, monitoring or display scale (including colour and other visual indicators) of in vitro diagnostic devices are designed and manufactured in line with recognised ergonomic principles, especially taking account of the intended functions of in vitro diagnostic device.

74. In relation to in vitro diagnostic devices which are instruments or apparatus with a measuring function, it shall be observed that:

74.1. in vitro diagnostic devices having a primary analytical measuring function are designed and manufactured in such a way as to provide stability and accuracy of measurement, taking into account the functions of in vitro diagnostic device and available reference measurement procedures and materials; and

74.2. when values are expressed numerically, they are to be given in legal units specified in applicable standards.

75. In relation to protection against ionising radiation emitted by the relevant in vitro diagnostic device, it shall be observed that:

75.1. in vitro diagnostic devices are designed, manufactured and packaged in such a way that exposure of users and third persons to the ionising radiation is minimised as far as possible;

75.2. if it is included within the functions of in vitro diagnostic device to emit ionising radiation in hazardous doses, in vitro diagnostic devices are designed and manufactured in such a way as to ensure the possibility to control parameters of radiation and are equipped with visual displays or audible warning systems of such emissions; and

75.3. the operating instructions for in vitro diagnostic devices emitting ionising radiation give detailed information as to the nature of the emitted ionising radiation, means of protection, on ways of avoiding use of in vitro diagnostic device in non-compliance with its functions, as well as of eliminating the risks inherent in installation.

[31 March 2009]

76. In relation to in vitro diagnostic devices with energy sources and in vitro diagnostic devices connected to energy sources, it shall be observed that:

76.1. in vitro diagnostic devices incorporating electronic programmable systems and software intended for them are designed to ensure the repeatability, reliability and performance of these systems according to the functions of in vitro diagnostic device;

76.2. in vitro diagnostic devices are designed and manufactured in such a way as to minimise the risks of creating electromagnetic perturbation which could impair the operation of other devices or equipment in the environment; and

76.3. in vitro diagnostic devices are designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during their use in compliance with the instructions of the manufacturer and in case of damage.

77. In relation to protection against mechanical and thermal risks caused by in vitro diagnostic devices it shall be observed that:

77.1. in vitro diagnostic devices are designed and manufactured in such a way as to protect the user against mechanical risks caused by in vitro diagnostic device;

77.2. in vitro diagnostic devices retain stability under the foreseen operating conditions;

77.3. in vitro diagnostic devices withstand stresses to which they are subjected in the foreseen operating conditions during all the expected life of in vitro diagnostic device provided by the manufacturer;

77.4. where there are risks to the health or life of the user due to the presence of moving parts, risks due to break-up or detachment, or leakage of substances of in vitro diagnostic devices, the appropriate protection means are available;

77.5. protection means included with in vitro diagnostic device provide intended protection, but not adversely affect functions and maintenance of in vitro diagnostic device;

77.6. in vitro diagnostic devices are designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration and noise generated by in vitro diagnostic devices, taking account of technical progress, particularly at source thereof (except the cases when the relevant vibration or noise is one of the intended operations of in vitro diagnostic device);

77.7. terminals and connectors to electricity, hydraulic and pneumatic energy supplies are designed and manufactured in such a way as to minimise all possible risks to the health and life of users; and

77.8. parts of in vitro diagnostic devices which come into contact with a user, excluding the parts or areas intended to supply heat or reach given temperatures, and their surroundings do not attain temperatures specified in the instructions of the manufacturer, if in vitro diagnostic device is used in compliance with the instructions of the manufacturer.

78. In relation to in vitro diagnostic devices intended to be used by lay persons in a home environment (hereinafter - devices for self-testing), it shall be observed that:

78.1. devices for self-testing are designed and manufactured in such a way that they perform appropriately for their intended functions especially taking into account the level of preparedness of a patient and the skills, as well as foreseeing variation in technique and environment of use of the device for self-testing;

78.2. the information provided in the instructions or on the label is easily understood;

78.3. devices for self-testing are designed and manufactured in such a way as to ensure that the device is easy to use by the intended lay user in compliance with their functions at all stages of the procedure, and reduce the risk possibility of user error in the handling of the device, as well as in the interpretation of the results; and

78.4. devices for self-testing, where reasonably possible, include a function which provides a possibility for a patient to verify that the product performs in accordance with its intended purpose.

79. A manufacturer shall attach to each in vitro diagnostic device the information regarding its safe and proper use, including the referred to information in the instructions for use or placing it on the label.

80. The information regarding safe and proper use of in vitro diagnostic device shall be placed on the device itself or, where necessary, on the sales packaging. If it is not possible to pack each unit individually, the referred to information shall be set out on the packaging or in the instructions for use supplied with several in vitro diagnostic devices.

81. Instructions for use shall be supplied with in vitro diagnostic devices or be included in the packaging of one or more in vitro diagnostic devices. No such instructions for use are needed for in vitro diagnostic device if the purpose for which in vitro diagnostic device is intended can be understandable for a lay user without them.

82. The information provided by the manufacturer may take also the form of symbols provided that all symbols and identification colour used conform to the applicable standards. If there are no relevant standards, the symbols and colours used shall be specified and described in the documentation supplied with in vitro diagnostic device.

83. Danger symbols specified in the regulatory enactments regulating placing on the market of dangerous goods shall be placed on the label of in vitro diagnostic devices or in vitro diagnostic devices themselves which may be considered as being dangerous, taking account of the properties and quantity of its constituents, as well as the form under which they are placed on the market. Where there is insufficient space to put all the necessary information on in vitro diagnostic device or on its label, the relevant symbols shall be put partly on the label and in the instructions for use.

84. The label of in vitro diagnostic device shall bear the following particulars:

84.1. the name and address of the manufacturer;

84.2. the name and address of the authorised representative, if in vitro diagnostic device is manufactured outside the European Union, but it is intended to put it on the market in the European Union;

84.3. characterisation and functions of in vitro diagnostic device;

84.4. the word "STERILE", if in vitro diagnostic device is sterile, or a statement indicating regarding special microbiological state or state of cleanliness;

84.5. the batch code, preceded by the word "LOT", or the serial number;

84.6. if necessary, an indication of the date by which in vitro diagnostic device or part of it may be used, in safety, without degradation of functions of in vitro diagnostic device (expressed as the year, the month and, where relevant, the day);

84.7. if in vitro diagnostic device is intended for performance evaluation, the words "for performance evaluation only";

84.8. a statement regarding use of the device for in vitro diagnostic only;

84.9. any particular handling or storage conditions;

84.10. any indications regarding action to be performed in order in vitro diagnostic device to be safe for a patient, user, third persons and the environment;

84.11. necessary warnings and precautions to take; and

84.12. in relation to devices for self-testing - indication that the device is intended for self-testing.

85. If the intended purpose and functions of in vitro diagnostic device is not obvious to the lay user, they shall be stated in the instructions for use and, if appropriate, also on the label.

86. In vitro diagnostic devices and separate parts (components) thereof shall be identified in terms of batch code or series number. The referred to number shall be assigned by the manufacturer ensuring identification of the manufacturer especially in relation to detachable components of in vitro diagnostic devices.

87. The instructions for use of in vitro diagnostic device shall contain the following particulars:

87.1. the details referred to in Paragraph 84 (with the exception of Sub-paragraphs 84.5 and 84.6) of this Regulation;

87.2. an indication regarding the composition of the reagent product or concentration of the active ingredient of the reagent or kit, as well as an indication, where appropriate, that in vitro diagnostic device contains other ingredients which might influence the measurement;

87.3. the storage conditions and indication regarding shelf life following the first opening of the primary container, together with the storage conditions and foreseeable indicators of stability of working reagents;

87.4. characterisation and functions of in vitro diagnostic device;

87.5. an indication of any special equipment required including information which helps a user to determine the suitability of a particular device together with the relevant in vitro diagnostic device;

87.6. the types of specimen to be used, conditions of collection, pre-treatment and storage of specimen, as well as instructions for the preparation of the patient;

87.7. a detailed description of the procedure to be followed in using in vitro diagnostic device;

87.8. the measurement procedure to be followed including:

87.8.1. measurement method;

87.8.2. an indication regarding the specific analytical performance characteristics (for example, sensitivity, accuracy, repeatability), limitations for application of particular methods, as well as information about available reference measurement procedures and materials to be used;

87.8.3. procedures after performance of measurements or handling before use of in vitro diagnostic device;

87.8.4. the indication whether any particular training is required;

87.9. the mathematical approach upon which the calculation of the analytical result is made;

87.10. measures to be taken in the event of changes in the analytical performance of in vitro diagnostic device;

87.11. information on internal quality control and the traceability of the calibration of in vitro diagnostic device, including on specific validation procedures;

87.12. an indication on the reference intervals for the quantities being determined, including a description of the appropriate reference population;

87.13. if in vitro diagnostic device is used in combination with other device, information on its characteristics to identify the correct in vitro diagnostic devices or equipment to use in order to obtain a safe and functional combination;

87.14. the information needed to verify whether in vitro diagnostic device is properly installed and can operate in compliance with the safety requirements;

87.15. details on intensity of the maintenance and frequency of calibration of in vitro diagnostic device needed to ensure proper and safe operation thereof;

87.16. information about waste management arising from use of in vitro diagnostic device;

87.17. the necessary instructions in the event of damage to the protective packaging, as well as details of appropriate methods of resterilisation or decontamination;

87.18. if in vitro diagnostic device is reusable, information on the appropriate processes to allow reuse of in vitro diagnostic device, including cleaning, disinfection, packaging and resterilisation or decontamination, as well as indication on any restriction on the number of reuses;

87.19. information on precautions to be taken as regards exposure to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources and impact of other conditions of external environment on in vitro diagnostic devices;

87.20. information on special precautions to be taken against any special risks related to the use or disposal of the in vitro diagnostic devices;

87.21. where the in vitro diagnostic device includes substances obtained from human or animal organs, information on their potential infectious nature;

87.22. specifications for devices for self-testing, including:

87.22.1. the form of expression of the results easily understandable by a person without relevant special knowledge;

87.22.2. information on action to be taken by a user in case of positive, negative or indeterminate result;

87.22.3. an indication on the possibility of error in the results presented by a device for self-testing, as well as on the volume of the error;

87.22.4. general information necessary to enable the patient, who uses the device for self-testing, to use and to understand the results produced;

87.22.5. a warning clearly directing that the patient should not take any medical treatment actions without first consulting his or her medical practitioner;

87.22.6. the information specifying that when the device for self-testing is used for the monitoring of an existing disease, the patient should only adapt the treatment if he or she has received the appropriate training to do so; and

87.23. date of drawing up of the instructions for use and date of latest revision thereof.

5. Rights and Obligations of the Agency and Inspectorate

[13 October 2009]

88. The Agency shall keep the electronic database of the register of medical devices LATMED (hereinafter - LATMED) where the information regarding devices referred to in Paragraph 20 of this Regulation, their manufacturers, distributors, regarding accidents related to the use of medical devices, as well as other information, which in accordance with this Regulation the Agency has the duty or right to obtain and store, is kept. In relation to medical devices manufactured in Latvia and marked with CE marking, LATMED shall be a permanent part of the common register of European Union Member States for market supervision of medical devices EUDAMED (hereinafter - EUDAMED).

[22 July 2008]

89. Information, which the Agency and the bodies referred to in Paragraphs 3 and 173 of this Regulation obtain in the process of notification, conformity assessment, distribution, maintenance and technical supervision of medical devices, shall be restricted access information. This provision shall not affect the obligation in relation to mutual exchange of information (also distribution of warnings) between competent authorities of other European Union Member States.

[22 July 2008]

90. The Agency shall inform the competent authorities of other European Union Member States regarding certificates of conformity issued by the notified bodies of the Republic of Latvia, which are suspended or annulled, and - upon receipt of the relevant request - also regarding certifications of conformity, which have been issued or refused, as well as regarding medical devices non-conforming to essential requirements discovered as a result of the operation of the vigilance system.

90.1 The Agency shall submit the European Commission a substantiated request to perform changes in classification of medical devices in the following cases:

90.11. if a decision regarding classification of a given device or category of devices is required for the application of the classification criteria referred to in Annex 1 to this Regulation;

90.12. if a given device or family of devices are to be classified, by way of derogation from the requirements referred to in Annex 1 to this Regulation, in another class;

90.13. if the conformity of a device or family of devices is to be established, by applying solely one of the conformity procedures by choice; or

90.14. if a decision on whether a given product or group of products complies with any of the criteria of the classification system is to be taken.

[31 March 2009]

90.2 The Agency shall inform the European Commission and the Member States regarding a decision taken in relation to withdrawal of a given product or group of products from the market or applied restriction, prohibition or regarding special requirements for the placing on the market or the putting into service in order to ensure the public health protection requirements specified in this Regulation.

[31 March 2009]

91. The Agency shall, in relation to activities with LATMED, be considered as the State information system manager within the meaning of the Law On State Information Systems.

92. In implementing the supervision of medical devices and in performing other duties specified in this Regulation, the Agency, in addition to the other rights granted and duties specified in this Regulation, is entitled:

92.1. to develop and publish programmes, guidelines, lists, instructions and information exchange documents necessary for the supervision of the distribution of medical devices, as well as to recommend the limited liability company "Standardisation, Accreditation and Metrology Centre" the list of standards to be adapted;

92.2. in accordance with Paragraphs 194 and 195 of this Regulation to establish a centralised electronic informative database regarding incidents or potential incidents in order to prevent operatively risks to health and life of a patient, user and third persons; and

92.3. to establish and keep electronic informative database regarding use of certain groups of medical devices (active and non-active implantable devices, devices in which human blood or human plasma derivatives are used, devices which have been manufactured using ingredients of animal tissue origin and other devices of increased medical risk).

[13 October 2009]

92.1 In implementing production (manufacture), distribution, operation and technical supervision of medical devices, as well as in performing other duties specified in this Regulation, the Inspectorate, in addition to other rights granted and duties specified in this Regulation, is entitled:

92.11. to control the production (manufacture) of medical devices, as well as to supervise the compliance of medical devices in the circulation and operation and of the services related thereto with the requirements of this Regulation;

92.12. to request and receive free of charge the information, including a copy of the declaration of conformity and technical documentation or a copy of the part which is necessary for the safety assessment of medical devices in the circulation and in use and of the services related thereto;

92.13. to request and receive free of charge samples of medical devices from a manufacturer or distributor (if it is possible and is not in contradiction with this Regulation, the Inspectorate shall, after performance of all necessary examinations and operations, return them respectively to the manufacturer or distributor) and supervise laboratory expert-examination or expert-examination of other type of a medical device or services related thereto;

92.14. to perform random control measurements for determination of the quality and efficiency of the technical supervision of medical devices at the places of use, manufacture and sale of medical devices in order to assess reliability of the information and reports notified by the manufacturer;

92.15. to perform expert-examination of medical devices in accordance with the procedures specified in this Regulation and other regulatory enactments regulating the field of medical devices, to take decisions in relation to cases of violation of regulations for manufacture, sale, safe operation, technical supervision of medical devices, which are of poor quality, incorrectly or unjustifiably marked with CE marking and unsafe, and of consumer rights;

92.16. to supervise activity of any person which places on the market or uses medical devices in the professional environment (in medical treatment and other institutions) or performs technical supervision or maintenance of medical devices;

92.17. to supervise distribution of medical devices in accordance with the rights which have been determined for market supervision institutions in the Law On Safety of Goods and Services; and

92.18. to develop and publish programmes, guidelines, lists, instructions and information exchange documents necessary for ensuring the supervision of distribution of medical devices.

[31 October 2009]

6. Registration and Conformity Assessment of Medical Devices

93. The Agency shall include medical devices in LATMED after receipt of the notification referred to in Paragraph 20 of this Regulation.

[22 July 2008]

94. In order to include a medical device in LATMED, the documents referred to in Paragraph 97, 98 or 102 of this Regulation shall be submitted to the Agency, and the Agency shall examine whether the referred to documents comply with the requirements of this Regulation in respect of their content and form.

95. [22 July 2008]

96. [22 July 2008]

97. In order to register a medical device manufactured in the Republic of Latvia, a submitter (a manufacturer or an authorised representative thereof) shall submit the following documents:

97.1. a submission in which the manufacturer's address (legal address and address of the place of commercial activity), the firm name and name of the medical device (in Latvian and English), as well as all names of modification variants of the device shall be included;

97.2. a copy of the submitter's registration certificate (upon presenting the original);

97.3. technical documentation of the medical device, in which information regarding the model of the medical device and all modification variants thereof shall be included. If the design of the medical device is simple and it is not a medical device of safety group 1 or 2, the technical documentation may be documented as a standard of the manufacturer or technical regulations of the manufacturer with section or technical file in which descriptions of the medical device, explanations, methods used in the manufacture, risk analysis, applied standards, results of development calculations and of examinations performed, trial reports, label and instructions for use shall be included regarding medical device;

97.4. upon a substantiated request of the Agency - a sample of packaging and labelling of the medical device, as well as samples of the medical device in original packaging;

97.5. EC declaration of conformity drawn up by the manufacturer and other certifications regarding conformity assessment procedures performed for the medical device by the notified body;

97.6. a certification regarding guarantees and how maintenance services, supply, installation and maintenance for medical devices which are not intended for a single use will be ensured;

97.7. for ionising radiation devices - a licence for operations with ionising radiation sources;

97.8. for disinfection products - safety data sheet; and

97.9. a permit specified in the Washington Convention on International Trade in Endangered Species of Wild Fauna and Flora of 1973 (CITES permit) and issued by the Nature Protection Board, if ingredients of protected or endangered wild plant or animal origin have been used in the manufacture of the device.

[22 July 2008]

98. Manufacturers of in vitro diagnostic devices, the location of which is the Republic of Latvia and which place such devices on the market with their name, shall, in addition to the information referred to in Paragraph 97 of this Regulation, submit all the necessary information to the Agency regarding:

98.1. the reagents, reagent products, calibration and control materials in terms of common technological characteristics and analysis, as well as the information regarding any significant change thereto (including discontinuation of placing on the market) and other necessary information; and

98.2. in the case of in vitro diagnostic devices of Lists A and B covered by Annex II to this Regulation and of devices for self-testing - regarding all data allowing for identification of such medical devices, the analytical and, where appropriate, diagnostic parameters, the outcome of performance evaluation, certificates and any significant change thereto (including discontinuation of placing on the market).

99. The Agency shall notify the information referred to in Paragraph 98 of this Regulation to EUDAMED.

100. The requirements referred to in Paragraph 98 of this Regulation shall also apply to any new medical device (also to active implantable medical device and in vitro diagnostic device) which has not been available on the European Union market during the previous three years and which has innovative indicators, as well as the procedure performed by which involves analytical technology not continuously used in connection with a given analyte or other parameter on the European Union market during the previous three years.

101. If the type specimen or production technology is changed for medical devices manufactured and already registered in the Republic of Latvia or if a new variant of the type specimen of the referred to devices is placed on the market, a manufacturer shall, prior placing it on the market or distribution, provide the information to the Agency in accordance with Paragraphs 97 and 98 of this Regulation and the Agency shall respectively supplement the information included in LATMED.

102. In order to register medical devices not marked with CE marking, the following shall be submitted to the Agency:

102.1. a submission in which the name, address of the manufacturer, as well as the name of the medical device (in Latvia and English) and all names of modification variants of the medical device are specified;

102.2. an official authorisation which attests that an authorised representative (any natural or legal person registered in the European Union who has been clearly authorised by the manufacturer to act and to whom the Agency, medical treatment institutions, organisations, medical practitioners or patient may apply instead of the manufacturer on matters in relation to the commitments determined for the manufacturer in compliance with the requirements of this Regulation) is entitled to register and distribute a given medical device in the Republic of Latvia;

102.3. a copy of the registration certificate (presenting the original) of a submitter who is the officially authorised representative of the manufacturer in the Republic of Latvia;

102.4. technical documentation of the medical device which includes information regarding the model of the medical device and all modification variants thereof (any significant information, descriptions, explanations, methods used in the manufacture, risk analysis, applied standards, results of development calculations and of examinations performed, trial reports, label and instructions for use);

102.5. upon a substantiated request of the Agency - a sample of packaging and labelling of the medical device, as well as samples of the medical device in original packaging;

102.6. conformity certifications regarding the device to be registered which have been issued by the notified bodies;

102.7. a copy of the registration certificate (presenting the original) issued by the competent authority which is responsible for the registration of the medical device in the state where is the place of commercial activity of the relevant manufacturer;

102.8. clinical investigation data, safety data and other significant information;

102.9. a certification regarding guarantees and how maintenance services, supply, installation and maintenance for medical devices which are not intended for a single use will be ensured;

102.10. a certification on how the measures of vigilance system (including notifying the Agency regarding any incident or situation which has caused or may have caused risk or damage to the health or life of a patient, user or third person);

102.11. documents necessary in registering certain groups of medical devices (for ionising radiation devices - a licence for activities with sources of ionising radiation, for disinfection products - a safety data sheet); and

102.12. where necessary, the information referred to in Sub-paragraphs 98.1 and 98.2 of this Regulation.

[22 July 2008; 31 March 2009]

103. A submitter shall submit all documents regarding medical devices manufactured in the Republic of Latvia in the official language.

104. Where necessary, the Agency may request certified translations of the documents regarding medical devices manufactured in third countries.

105. In order to ensure complete registration process, the Agency is entitled to request the necessary additional information - an opinion of the Central Medical Ethics Committee, professional associations of physicians or another competent authority regarding the medical device applied for registration.

[13 October 2009]

106. If the documents referred to in Paragraphs 97, 98, 102 and 105 of this Regulation have not been submitted or the necessity to clarify significant facts occurs during the registration process, the registration procedure shall be suspended and the Agency shall send a written request to the submitter to submit the requested documents or provide the necessary information within 60 days. If the submitter fails to submit the necessary information or requested documents within the referred to period of time, the Agency shall take a decision to refuse registration.

107. [22 July 2008]

108. [22 July 2008]

109. [22 July 2008]

110. [22 July 2008]

111. [22 July 2008]

112. [22 July 2008]

113. [22 July 2008]

114. [22 July 2008]

115. [22 July 2008]

116. [22 July 2008]

117. [22 July 2008]

118. [22 July 2008]

119. [22 July 2008]

120. The Agency shall allow to place on the market in the Republic of Latvia certain medical devices for which the conformity assessment procedures referred to in this Regulation have not been performed and which do not have CE marking, but which are used for health care in the following cases:

120.1. a medical device is supplied individually upon order for a particular patient; or

120.2. a medical device is distributed in limited manner and used for needs of a particular medical treatment institution and it is certified by a motivated submission of the head of the medical treatment institution.

[22 July 2008]

120.1 In taking a decision regarding issue of the permit referred to in Paragraph 120 of this Regulation, the Agency shall base on the following criteria:

120.11. a certificate issued by a competent authority of the country of origin of a medical device with indications regarding safety and quality of the device;

120.12. a document issued by a supervision institution of the country of origin of a medical device with indications regarding safety and quality of the device;

120.13. certifications issued by the manufacturer of a medical device regarding safety and quality of the device;

120.14. manufacture management quality certificate issued to the manufacturer of a medical device;

120.15. detailed technical description of a medical device;

120.16. detailed information on use of a medical device with indications regarding safety requirements for patients and users of the device; and

120.17. an opinion of the relevant professional association of medical practitioners of Latvia or a council of physicians-specialists regarding necessity and usefulness of a given medical device.

[31 March 2009]

121. The conformity with the requirements of this Regulation shall be assessed during the conformity assessment process of medical devices. The manufacturer shall, prior to submission of a conformity assessment application, perform the risk assessment referred to in Annex 4 to this Regulation and implement a risk management scheme for the medical devices referred to in Paragraph 151 of this Regulation.

122. For the conformity assessment of medical devices, in order to receive conformity certification, the manufacturer or the authorised representative thereof shall mutually agree with the notified body regarding conformity assessment procedures in accordance with Chapter 7 of this Regulation, which are to be applied to a given medical device, and regarding time periods within which such conformity procedures will be performed. The notified body, upon due justification, may request the necessary information and data in order to perform conformity examination which is provided by the necessary conformity assessment procedures for a given medical device. Decisions taken by the notified body on the conformity of a given medical device shall be valid not longer than for five years.

[22 July 2008]

123. The notified body shall inform the Agency regarding conformity certifications issued, refused, revoked or suspended.

[22 July 2008]

124. The notified body may suspend, revoke or restrict the conformity certifications issued, if it is detected that the manufacturer fails to observe the requirements referred to in this Regulation.

[22 July 2008]

125. The Agency shall, in compliance with the competence thereof, assess the correctness of the conformity assessment procedures applied by the manufacturer and the notified body and whether CE marking is affixed correctly and justifiably. If CE marking is applied inappropriately, the Agency shall immediately turn to the manufacturer or the notified body and, if the non-compliance is not eliminated, shall immediately inform the European Commission and other European Union Member States thereof.

[22 July 2008]

126. In order to promote introduction of new and modern medicinal technologies and informing of the society regarding free market possibilities of medical devices marked with CE marking in publicly available electronic informative database, the Agency shall maintain and, in accordance with a submission of a submitter, supplement the information regarding all medical devices marked with CE marking available in the Republic of Latvia. Informative database shall also ensure concurrently the efficiency of the operation capacity of the vigilance system and protection of patients, users and third persons against accidents, especially relating to Class IIb and Class III medical devices, active implantable medical devices, non-active implantable medical devices and materials referred to in List A and List B of Annex 2 to this Regulation and in vitro medical devices for self-testing and medical devices which have been manufactured utilising animal tissues which are rendered non-viable and products of the origin of such tissues.

[22 July 2008]

127. [22 July 2008]

7. Provisions for Registration and Conformity Assessment of Certain Classes of Medical Devices and Such Medical Devices which are not Manufactured Commercially

128. In registering or subjecting used, renewed, modified or rebuilt medical devices to conformity assessment, a submitter shall, in addition to the documents and information referred to in Paragraphs 97, 98 and 102 of this Regulation, submit certifications of conformity which prove that the medical device complies with all quality, safety and efficiency requirements applicable to the device of such type even after renewal, modification or rebuilding.

129. In the case of medical devices falling within Class III and other than medical devices which are custom-made or medical devices intended for clinical investigations, the manufacturer shall, in order to affix the CE marking (to give the right to the manufacturer to mark medical device with CE marking), follow one of the following procedures:

129.1. the procedure referred to in Annex 5 to this Regulation;

129.2. the procedure referred to in Annexes 6 and 7 to this Regulation; or

129.3. the procedure referred to in Annexes 6 and 8 to this Regulation.

130. In the case of medical devices falling within Class IIa and other than medical devices which are custom-made or such medical devices intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow one of the following procedures:

130.1. the procedure referred to in Annexes 7 and 9 to this Regulation;

130.2. the procedure referred to in Annexes 8 and 9 to this Regulation;

130.3. the procedure referred to in Annexes 9 and 10 to this Regulation; or

130.4. the procedure referred to in Annex 5 (except Paragraphs 9, 10, 11, 12 and 13 thereof) to this Regulation.

[22 July 2008]

131. In the case of medical devices falling within Class IIb and other than medical devices which are custom-made or such medical devices intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow one of the following procedures:

131.1. the procedure referred to in Annex 5 (except Paragraphs 9, 10, 11, 12 and 13 thereof) to this Regulation;

131.2. the procedure referred to in Annexes 6 and 7 to this Regulation;

131.3. the procedure referred to in Annexes 6 and 8 to this Regulation; or

131.4. the procedure referred to in Annexes 6 and 10 to this Regulation.

[22 July 2008]

132. The manufacturer shall draw up an EC declaration of conformity in the cases referred to in Paragraphs 129, 130 and 131 of this Regulation.

133. In the case of medical devices falling within Class I and other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex 9 to this Regulation and draw up the EC declaration of conformity. In addition to that specified in relation to sterile Class I medical devices and medical devices with a measuring function, the manufacturer shall observe one of the following procedures:

133.1. the procedure referred to in Annex 8 to this Regulation;

133.2. the procedure referred to in Annex 10 to this Regulation; or

133.3. the procedure referred to in Annex 7 to this Regulation.

134. In relation custom-made medical devices, the manufacturer shall follow the procedure referred to in Annex 11 to this Regulation and draw up the statement set out in that Annex 11 to this Regulation and a statement regarding compliance with the essential requirements before placing the medical device on the market.

[21 September 2010]

135. In order to affix the CE marking to active implantable medical devices other than devices which are custom-made or intended for clinical investigations, the manufacturer shall draw up an EC declaration of conformity and follow one of the following procedures additionally:

135.1. the procedure referred to in Annex 12 to this Regulation;

135.2. the procedure referred to in Annexes 13 and 14 to this Regulation; or

135.3. the procedure referred to in Annexes 13 and 15 to this Regulation.

136. In order to place on the market individually made active implantable medical devices, the manufacturer shall, prior placing on the market of each such medical device, draw up the statement referred to in Annex 16 to this Regulation.

[31 March 2009]

137. Decisions of the notified body taken in accordance with Annexes 12 and 13 to this Regulation shall be valid not longer than for five years. If the relevant application is submitted to the notified body, time period of such decision may be extended repeatedly for five years.

[22 July 2008]

138. In relation to all in vitro diagnostic devices (except the devices referred to in Annex 2 to this Regulation) the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex 17 (except Paragraph 6 thereof) to this Regulation.

139. All in vitro diagnostic devices (except devices for performance evaluation), the manufacturer shall draw up an EC declaration of conformity.

140. In relation to all self-testing devices (except the glucose meters referred to in List B of Annex 18 to this Regulation) the manufacturer shall follow one of the following procedures:

140.1. the procedure referred to in Annex 17 (including Paragraph 6 thereof) to this Regulation;

140.2. the procedure determined for devices of List A of Annex 2 to this Regulation; or

140.3. the procedure determined for devices of List B of Annex 2 to this Regulation.

141. In relation to all in vitro diagnostic devices of List A of Annex 2 to this Regulation (except devices for performance evaluation) the manufacturer shall, in order to affix the CE marking, follow one of the following procedures:

141.1. the procedure referred to in Annex 19 to this Regulation; or

141.2. the procedure referred to in Annexes 18 and 20 to this Regulation.

142. In relation to all in vitro diagnostic devices of List B of Annex 2 to this Regulation (except devices for performance evaluation) the manufacturer shall, in order to affix the CE marking, follow one of the following procedures:

142.1. the procedure referred to in Annex 19 to this Regulation;

142.2. the procedure referred to in Annexes 18 and 21 to this Regulation; or

142.3. the procedure referred to in Annexes 18 and 20 to this Regulation.

143. In relation to in vitro diagnostic devices for performance evaluation, the manufacturer shall follow the procedure referred to in Annex 22 to this Regulation and draw up the statement set out in the referred to Annex and a statement regarding conformity with the essential requirements before such devices are placed on the market.

144. The manufacturer shall keep the declaration of conformity, the technical documentation referred to in Annexes 17, 18, 19, 20, 21 and 22 to this Regulation, as well as the decisions, reports and certificates regarding in vitro diagnostic devices and, where necessary, make it available to the national authorities for inspection purposes for a period ending five years after the last in vitro diagnostic device has been manufactured. Where the manufacturer is not established in the European Union, the obligation to make the referred to documentation available upon request applies to his authorised representative.

145. Decisions of the Agency and the notified body taken in accordance with Annexes 17, 18 and 19 to this Regulation in respect of in vitro diagnostic devices shall be valid not longer than for five years. If a relevant application is submitted, this time period may be extended repeatedly for a period of time not exceeding five years.

[22 July 2008]

146. The Agency, upon a submission of the manufacturer to which an opinion of the council of physicians regarding necessity of a medical device is appended, may allow to place on the market in the Republic of Latvia such in vitro diagnostic devices for which the procedures of conformity assessment referred to in this Regulation have not been performed and which do not have CE marking and which are used in health care.

146.1 In taking a decision regarding issue of the permit referred to in Paragraph 146 of this Regulation, the Agency shall base on the following criteria:

146.11. a certificate issued by a competent authority of the country of origin of a medical device with indications regarding safety and quality of the device;

146.12. a document issued by a supervision institution of the country of origin of a medical device with indications regarding safety and quality of the device;

146.13. certifications issued by the manufacturer of a medical device regarding safety and quality of the device;

146.14. manufacture management quality certificate issued to a manufacturer of a medical device;

146.15. detailed technical description of a medical device; and

146.16. detailed information on use of a medical device with indications regarding safety requirements for patients and users of the device.

[31 March 2009]

8. Special Provisions for Systems and Procedure Packs

147. Any natural or legal person who puts medical devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack, shall draw up a declaration and submit it to the Agency by which he or she states that:

147.1. the mutual compatibility of the medical devices has been verified in accordance with the manufacturers' instructions;

147.2. the system or procedure pack has been packaged and the relevant information to users incorporating instructions for use which comply with the requirements referred to in this Regulation have been supplied thereto; and

147.3. in performing the activities referred to in Sub-paragraphs 147.1 and 147.2 of this Regulation, the relevant methods of internal control and inspection have been used.

148. Where the conditions referred to in Paragraph 147 of this Regulation are not met (as in cases where the system or procedure pack incorporates medical devices which do not bear a CE marking or where the chosen combination of medical devices is not compatible in view of their original intended functions), the system or procedure pack shall be treated as a medical device in its own right and as such be subjected to the relevant conformity assessment procedure in accordance with Chapter 7 of this Regulation.

149. Any natural or legal person who sterilized, for the purpose of placing on the market, systems or procedure packs referred to in Paragraph 147 of this Regulation, shall, at his or her choice, follow one of the procedures referred to in Annex 7, 8 or 10 to this Regulation. The relevant person shall draw up and submit to the Agency a declaration stating that sterilization has been carried out in accordance with the manufacturer's instructions.

150. The products referred to in Paragraphs 147, 148 and 149 of this Regulation themselves shall not bear an additional CE marking, but the manufacturer shall submit to the Agency the information referred to in Paragraphs 38, 39, 40, 41, 42, 43, 44, 45 and 46 of this Regulation. The declaration referred to in Paragraphs 147 and 149 of this Regulation shall be kept for five years.

9. Special Provisions for Tissue Medical Devices

[22 July 2008]

151. This Chapter specifies technical requirements for tissue medical devices in relation to risks of transmitting transmissible spongiform encephalophathies (TSE) to patients or other persons using such devices in compliance with their intended functions. The provisions of this Chapter shall not apply to tissue medical devices which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only.

[22 July 2008]

152. Paragraph 151 of this Regulation shall apply to tissue medical devices manufactured utilising bovine, ovine, caprine, deer, elk, mink and cat tissues which are rendered non-viable (incapable to metabolism or reproduction).

[22 July 2008]

153. Collagen, gelatine and tallow used for the manufacturing of tissue medical devices shall meet at least the requirements which have been determined for their use in food for human consumption.

154. The conformity assessment procedure for tissue medical devices shall include the evaluation of their compliance with the essential requirements referred to in Chapter 2 of this Regulation and the evaluation of their compliance with technical requirements referred to in Paragraph 129 and Annex 4 to this Regulation.

155. The notified body shall, in the conformity assessment process, assess the manufacturer's risk analysis and the risk management strategy, including:

155.1. the information provided by the manufacturer;

155.2. the justification for the use of animal tissues (organisation of cells (the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment) or extra-cellular constituents) or derivatives (a material obtained from an animal tissue by a manufacturing process such as collagen, gelatine, monoclonal antibodies);

155.3. inactivation and elimination studies or the review and analysis of appropriate scientific literature;

155.4. the manufacturer's control of the sources of raw materials, finished products and subcontractors; and

155.5. the need to audit matters related to sourcing, including third party supplies.

[22 July 2008; 13 October 2009]

156. Notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, where such certificate is available in the relevant case.

[22 July 2008]

157. The notified body shall, in co-operation with a competent authority, seek the opinion of the competent authorities of the other Member States on their evaluation of and conclusions on the risk analysis and risk management of the tissues or the derivatives intended to be incorporated in the tissue medical device as established by the manufacturer. This provision shall not apply to tissue medical devices in which raw materials (raw materials or all other products of animal origin from which or via which the devices referred to in Paragraph 151 of this Regulation are manufactured) are used for which TSE certificate of conformity is issued.

[22 July 2008]

158. Before issuing an EC design-examination certificate or an EC type-examination certificate, the notified body shall take into account all opinions provided in accordance with the procedures referred to in Paragraph 157 of this Regulation, if they have been received within 12 weeks from the date on which the opinion was sought.

[22 July 2008]

10. Safety Groups of Medical Devices and Types of Incidents

159. Medical devices shall be divided in the following safety groups:

159.1. group 1 - devices of high possible technical risk during the use of which risk factors (electric current, radiation, mechanical and other type of energy, biological, chemical, environmental and other factors or errors in dosage systems) may directly and significantly affect the health of a patient, user or third person or endanger the life of the referred to persons or cause damage to the property;

159.2.group 2 - devices of medium technical risk which are operating using electrical or other type of energy and thus shall be classified as active medical devices or devices with measuring function; and

159.3. group 3 - devices of low possible technical risk - all devices which are not included in the first two groups.

[22 July 2008]

160. The list of medical devices, in which particular medical devices (devices) are listed according to their division by safety groups, is specified in Annex 23 to this Regulation.

161. All cases of use of medical devices of safety group 1 and 2 shall be registered precisely in a special register of use and accounting in order to ensure traceability within the framework of continuous surveillance or vigilance system. Such accounting shall be ensured in each medical treatment institution or other institution where the referred to devices are used regardless of that whether the relevant device is used in compliance with medical or other indications.

[22 July 2008]

162. If the information is changed regarding use of medical devices of certain safety groups, the distributors and users of medical devices shall provide the information to the Agency necessary for updating of registers in relation to a particular medical device.

163. The types of incidents related to the use of medical devices shall be as follows:

163.1. type 1 - incidents as a result of which the death of a patient, user of third person occurs;

163.2. type 2 - incidents when due to use of device damage has been caused to the health of a patient, user or third person; and

163.3. type 3 - incidents when the malfunction of a device or deviations in the specified basic parameters have been detected due to which damage may have been caused to the health of a patient, user or third person, or there is a possibility of incident occurrence, because the manufacturer, the authorised representative thereof or distributor fails to fulfil the guarantee commitments or has not ensured service and maintenance measures for a device, where it was necessary, including qualified repair, or an incident has occurred due to which damage has been caused to the property of a patient, user or third person.

164. In case of an incident of type 1 or 2 (if necessary - also type 3):

164.1. a user of the medical device shall immediately unplug the device from the mains and other devices;

164.2. a user of medical device shall perform all the necessary in order the medical device cannot be used by other person and a warning inscription shall be affixed in a place of good visibility; and

164.3. a signal report (Annex 24) shall be drawn up immediately.

[31 March 2009]

165. A user of the medical device together with the owner or holder thereof shall, within three days after the incident, send a signal report to the manufacturer or the authorised representative of the manufacturer and distributor of the medical device, as well as to the Agency. The Agency shall follow the investigation procedure of the incident. If significant facts are discovered in further analysis of the situation, the user of the medical device together with the owner or holder thereof may supplement the signal report of the incident.

[31 March 2009]

11. Additional Requirements for Medical Devices of Safety Group 1 and 2

166. A medical device of safety group 1 and 2 may be used by a certified medical practitioner, if the device has been correctly installed, specifications for use microenvironment of the device specified by the manufacturer are ensured, power supply regimen is guaranteed (if such requirement is referred to in the documentation of the medical device), the use of spare parts certified by the manufacturer of the device is guaranteed in the technical maintenance agreement entered into and the device is used in compliance with the intended functions.

167. A medical device shall be installed and put into service by its manufacturer or an authorised and appropriately trained representative thereof, ensuring:

167.1. the examination of specifications for use environment of the devices requested in the technical documentation of the supplied medical device and transfer of such notes to the owner or holder of the medical device;

167.2. the examination of power supply regimen requested and guaranteed in the technical documentation of the supplied medical device;

167.3. training of the user of the medical device for at least 30 hours issuing a document certifying his or her competence;

167.4. transfer of instructions for use of the medical device and other documentation in Latvian and explanation of vigilance system operation to the user in relation to the given medical device;

167.5. metrological examination of the medical device, testing of functions and calibration of the device, if, upon commencement of operation thereof, such requirements have been provided for in the technical documentation; and

167.6. technical maintenance of the medical device during the specified guarantee period and during the resource period of the medical device notified by the manufacturer, if the owner or holder of the medical device selects such maintenance during the resource period.

168. An owner or holder of the medical device, shall, upon commencement of the operation of the device, ensure:

168.1. unambiguous identification of the medical device and place of permanent location thereof, as well as use of recognition and coding system developed in the institution;

168.2. for medical devices of safety group 1 - insurance of civil liability against possible damage to a patient, user and third person;

168.3. examination of electrical safety, main functions and specifications and metrological control of medical devices;

168.4. due technical maintenance of the medical device during the specified guarantee period and during the resource period notified by the manufacturer, as well as purposeful technical maintenance of the medical device during after-resource period thereof;

168.5. appointing of an appropriate qualified responsible official who solves matters regarding observation of the specified requirements and co-operates with the Agency and other bodies as an official contact person of the owner or holder;

168.6. sending the information regarding purchased medical devices of safety group 1 and 2 to the Agency within 30 days after purchase thereof.

169. An owner or holder of the medical device shall ensure that each medical device of safety group 1 and 2 is registered in a separate register, specifying the information regarding:

169.1. the date of the performance of technical supervision implemented by the notified technical examination body, name, surname of the expert, name of the performer of the supervision and number of the technical supervision statement;

169.2. malfunction of medical device occurred in correctly installed, maintained and exploited medical device, as well as regarding type thereof and consequences caused;

169.3. the time of detection of functional interference, as well as the name and surname of the person who has detected malfunction;

169.4. reason for malfunction;

169.5. measures for elimination of malfunction;

169.6. the date of performance of technical maintenance and repair, the name of the company and the name and surname of the person, who has performed the relevant works;

169.7. in the case of repeated malfunction - a notation regarding sending of a signal report on the incident of type 3 in accordance with Paragraphs 163, 164 and 165 of this Regulation.

170. Copies of the lists of works performed and parts replaced during technical maintenance and repair shall be appended to the register of the medical device.

12. Use, Operation and Technical Supervision of Medical Devices

171. Use, operation and technical supervision of medical devices is a set of measures or an operation system of medical devices, which expresses as control and supervision measures performed by the Inspectorate, examining whether the use, operation and maintenance of the medical device is performed in accordance with this Regulation.

[22 July 2008; 13 October 2009]

171.1 The operation system of medical devices shall include:

171.11. supervision of selection, compatibility (with medical devices in operation), purchase, installation, launching, use, device testing, calibration, metrology requirements, technical service guarantee of medical devices, as well as internal and external supervision of operation safety;

171.12. measures for operation and training of a user and technical service specialists (in order to ensure safety of users and third persons and protection of rights, when receiving health care or other service in which a medical device is used);

171.13. safe and environmentally friendly utilisation of medical devices.

[22 July 2008]

171.2 An operation system of medical devices shall be established by institutions which use more than 30 medical devices in the provision of service.

[22 July 2008]

172. The Inspectorate is entitled to perform supervision of use and operation of medical devices as far as it is within the framework of distribution supervision functions in accordance with this Regulation, distribution supervision provisions and the by-laws of the Inspectorate.

[13 October 2009; 21 September 2010]

173. Technical supervision of medical devices shall be performed by the body, which has been accredited in the limited liability company "Standardisation, Accreditation and Metrology Centre" in accordance with the standard LVS EN ISO/IEC 17020:2005 "General criteria for the operation of various types of bodies performing inspection" and regarding which the Ministry of Economics has published a notification in the newspaper Latvijas Vēstnesis (hereinafter - technical supervision body). Technical supervision body shall immediately notify the Inspectorate regarding any violations of this Regulation in the field of use, operation and maintenance of medical devices.

[31 March 2009; 13 October 2009]

173.1 The exchange of supervision and control information of medical devices shall be performed in compliance with the requirements of the standard LVS EN ISO 15225:2000 "Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange".

[22 July 2008]

174. Custom-made medical devices shall be placed on the market, if they comply with the essential requirements specified in Chapter 2 of this Regulation and the notification referred to in Annex 11 to this Regulation has been drawn up thereon and appended to the medical device. A manufacturer or the authorised representative thereof shall keep all the documentation regarding such devices for at least five years.

[22 July 2008; 21 September 2010]

175. Medical devices, which are intended for performance evaluation and which are available for such purpose in laboratories or other institutions, shall be placed on the market, if the procedure referred to in Paragraph 143 of this Regulation has been performed for them. All the documents regarding such devices shall be kept for at least five years.

176. Medical devices, which fail to comply with the requirements referred to in this Regulation, may be demonstrated in exhibitions and similar events, if the indication that a given medical device may not be placed on the market because it does not meet the requirements referred to in this Regulation is clearly visible.

177. If it is detected that CE marking is affixed unjustifiably or incorrectly, it is the duty of the manufacturer or the authorised representative thereof to eliminate such violation.

[22 July 2008]

178. [22 July 2008]

179. If the Agency detects that medical devices with CE marking, as well as custom-made medical devices, even appropriately installed, maintained and used in compliance with their intended functions, may cause damage to the health of a patient, user or third person, the Agency shall immediately inform the European Commission thereof, indicating whether non-compliance with the requirements referred to in this Regulation is related to:

179.1. non-fulfilment of essential requirements;

179.2. inappropriate application of standards (if it is stated that standards have been applied); and

179.3. deficiencies of the standards.

[22 July 2008]

180. If CE marking is affixed to any of medical devices non-complying with the essential requirements, the Agency shall inform the European Commission and other European Union Member States thereof.

[22 July 2008]

181. Users of medical devices shall inform the Agency regarding incidents and the Agency shall register and assess all the information on incidents, including:

181.1. regarding any malfunction or deterioration in the characteristics or performance of a medical device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a deterioration in his or her state of health; and

181.2. regarding any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in Sub-paragraph 181.1 of this Regulation, leading to systematic recall of medical devices of the same type by the manufacturer.

182. The Agency shall inform the manufacturer of the relevant medical device or the authorised representative thereof regarding any incidents referred to in Paragraph 181 of this Regulation, if such information has not been already provided in accordance with the procedures specified in Paragraphs 163, 164 and 165 of this Regulation.

183. After carrying out an assessment, if possible together with the manufacturer, the Agency shall, without prejudice to Paragraphs 179 and 180 of this Regulation, immediately inform the European Commission and other European Union Member States of the incident.

184. The Agency shall submit a substantiated request to the European Commission to carry out the necessary measures, if the application of the classification rules requires to take a decision regarding:

184.1. classification of a given medical device or category of devices;

184.2. whether a given device or family of devices should be classified, by way of derogation from the classification rules, in another class; and

184.3. whether the conformity of a medical device or family of devices should be established, by way of derogation from the provisions of the conformity assessment procedures, by applying solely one of the conformity assessment procedures.

185. Medical devices of safety group 1, active medical devices, active implantable medical devices and non-active implantable medical devices and materials shall be used only by a certified medical practitioner at an appropriately assessed medical treatment institution or other institution, if the particular medical practitioner has received a certificate attesting his or her competence after appropriate special additional training in use of the given implantable medical device or medical device of safety group 1 and 2 and if maintenance services of specially trained technical personnel are ensured for the institution for due upkeep of the medical device.

[22 July 2008]

186. Appropriate use of medical devices of safety group 1 and 2, active and non-active implantable medical devices and materials, as well as invasive medical devices shall be ensured regardless of whether the device is used in a medical treatment institution or in other institution and regardless of whether it is used only in accordance with medicinal indications or due to other reasons.

[22 July 2008]

187. Each case of use of medical devices of safety group 1 and 2 and active implantable medical devices and non-active implantable medical devices or materials shall be precisely registered in the log book of use, procedures or manipulations of the medical device regardless of whether the device is used in a medical treatment institution or in other institution and regardless of whether they are used in accordance with medicinal indications or due to other reasons in order to ensure traceability within the framework of continuous surveillance or vigilance system.

[22 July 2008]

12.1 Registration Criteria for Conformity Assessment Body of Medical Devices

[22 July 2008]

187.1 The purpose of the registration of an accredited conformity assessment body of medical devices (hereinafter - body to be registered) is to assess previous experience of merchants present in the market of medical devices, quality management systems and presence of technical means for conformity assessment, traceability and reliability of measurements.

187.2 A body to be registered shall conform to the following essential requirements:

187.21. sound vocational training of the staff covering all the conformity assessment and verification operations for which the body has been accredited; and

187.22. the staff has satisfactory knowledge of the regulatory enactments applicable during the inspections, as well as sufficient work experience and competence required to draw up the conformity records, statements or reports to demonstrate that the inspections ordered by a manufacturer of new medical devices have been carried out and the results obtained are reliable.

187.3 Employees of the body to be registered may not be the developers, manufacturers, suppliers, adjusters or users of the relevant devices to be inspected, as well as authorised representatives of any of the referred to persons.

187.4 The staff of the body to be registered may not be directly involved in the development, designing, trade or technical maintenance of medical devices to be inspected, as well as may not represent parties involved in such operations. (It does not exclude the possibility for the body to be registered and the manufacturer to exchange technical information).

187.5 The body to be registered shall perform assessment and verification operations with professional integrity and the requisite competence in the field of performance and safety of medical devices.

187.6 Should the notified body subcontract specific tasks of conformity assessment connected with the establishment and verification of the facts, the requirements of this Regulations shall be binding on the subcontractor. The body to be registered shall keep the relevant documents assessing the subcontractor's qualifications and the work carried out by the subcontractor (at the disposal of the state authorities and other interested parties).

187.7 The body shall carry out all the tasks intended for such bodies by the requirements of the limited liability company "Standardisation, Accreditation and Metrology Centre", and its competence in the conformity assessment of medical devices has been proven regardless of whether these tasks are carried out by the body itself or subcontractor on its assignment.

[31 March 2009; 13 October 2009]

187.8 The competent staff and necessary devices for conformity assessment and performance measuring of medical devices shall be at the disposal of the body to be registered.

187.9 In order to attest the competence in the conformity assessment of new medical devices, the body to be registered shall continuously develop quality management system and technical possibilities of the professional activity.

187.10 The body to be registered shall guarantee impartiality because remuneration for conformity assessment must not depend on the number of conformity assessments carried out, or on the results thereof.

187.11 The body to be registered has insured the civil liability thereof.

187.12 The staff of the body to be registered shall observe data protection requirements in relation to all information gained in the course of their duties in accordance with this Regulation and other regulatory enactments.

13. Vigilance System and Continuous Technical Supervision

188. Vigilance system is an aggregate of requirements specified in this Regulation which shall be observed by manufacturers of medical devices, authorised representatives thereof, distributors, owners, possessors and holders, and which provides for notification and measures for assessment of notifications with involvement of the Agency regarding any incident or potential incident related to the use of a medical device which has caused or could have caused damage to the health or endanger the life of a patient, user or third person.

189. An aggregate of measures of the vigilance system shall ensure the traceability possibility from the designing until the end of the intended term of use, but in relation to implantable devices - until the end of the operation of the implant.

190. Vigilance system is unified and suitable for all medical devices.

191. The purpose of the vigilance system is to ensure the possibility for the Member States to identify concurrently the model and series of inappropriate medical device in the circulation and use and prevent recurrence of incidents via use of the incident notification system of the users of medical devices in all European Union Member States.

192. During operation of a medical device an owner or holder of the medical device shall take into account the requirements of this Regulation which must be observed during the whole period of use of resources of medical device specified by the manufacturer and also after the end of such period of time, if the continuation of operation of the medical device is duly justified.

193. According to the electrical safety group of the medical device specified by the manufacturer, electrical safety inspections shall be ensured for all medical devices of safety group 1 and 2 registered with the institution at least once a year which are performed by the notified accredited technical assessment body, unless otherwise specified by the manufacturer of the medical device.

194. An owner or holder of the medical device shall electronically transfer to the Inspectorate the number of the statement of the current electrical safety inspection, opinion of the technical supervision body for a period of six months and the information regarding time of next inspection. This provision need not be applied by institutions, the number of devices of safety group 1 and 2 of which does not exceed 10.

[13 October 2009]

195. In case of fault of a medical device the possessor or holder thereof, in fulfilling the requirements of this Regulation, has the right to request that the manufacturer or the authorised representative thereof immediately supplies certified spare parts and acts respectively in order downtime of medical device of safety group 1 and 2 (if it is a technically complicated and unique medical device of high technologies) does not exceed 21 days, taking into account that:

195.1. in case of fault of device of safety group 1 and 2 only change of block spare parts certified by the manufacturer is allowed, registering the changed spare parts in the relevant section of the register of medical devices of safety group 1 and 2; and

195.2. any repair operations with block spare parts unauthorised by the manufacturer and repeated use thereof in a medical device is not permissible.

196. The conformity of functions of medical devices shall be tested and assessed by the body referred to in Paragraph 173 of this Regulation, taking into account the number of working hours of operation of the medical device or the number of procedures performed and the age of the medical device from the time of manufacture or beginning of the operation period. The conformity testing and assessment shall be performed at least:

196.1. once in two years, if the device is exploited for less than four years;

196.2. once a year, if the device is exploited four to seven years; or

196.3. twice a year, if the device is exploited for more than seven years (or a period of resources clearly specified by the manufacturer has been expired) and if the technical maintenance contracts entered into attest due fulfilment of the provisions referred to in Sub-paragraph 168.4 of this Regulation.

197. An owner or holder of a medical device shall ensure extraordinary electrical safety and metrological inspection, function conformity testing and calibration of the medical device after repair of the device or modernisation performed or authorised by the manufacturer observing the requirements of this Regulation regarding maximum permissible downtime referred to in Paragraph 195 of this Regulation.

198. A possessor or holder of a medical device shall ensure further training of users of the given medical device and officials appointed to be responsible for medical devices in the amount and quality required.

199. A technical supervision body shall, in implementing the supervision of the procedures of operation of medical devices in the institutions in the provision of services of which medical devices are used, perform unintentional inspections and measurements of safety of the medical device and conformity testing quality control of the function of devices without remuneration on random basis.

200. In case of doubts or uncertainties the possessor or holder of the medical device has the right to invite experts for re-testing of the conformity of the function specifications of the device after repair of the medical device.

201. Within the framework of continuous supervision or vigilance system the Agency shall, after receipt of a signal report on the incident from the possessor or holder of the medical device:

201.1. register the signal report of the incident;

201.2. initiate or perform interim measures appropriate for the category of the particular incident in relation to the medical device involved in the incident:

201.2.1. limit the use of the particular medical device or of all medical devices of this model;

201.2.2. prohibit the use of the particular medical device or of all medical devices of this model at all;

201.2.3. [22 July 2008];

201.3. control how the investigation of the incident is being carried out;

201.4. receive from the manufacturer initial report, interim reports necessary for the investigation of the incident and final report of the incident;

201.5. register all reports of the investigated incident;

201.6. upon consultation with the manufacturer, take a decision regarding the necessary corrective operations;

201.7. if the investigation process provides appropriate approvals for necessary corrective operations, inform the competent authorities of other European Union Member States and the European Commission regarding the incident; and

201.8. when the investigation of the incident has been finished and the final decision has been taken, as well as the necessary measures have been performed or suggested, the Agency shall terminate the case and inform the involved persons of the results of the investigation.

202. A manufacturer of a medical device shall be fully liable for the implementation of the necessary investigation operations in case of the incident regardless of the place of detection and investigation of the incident, ensuring the time record schedule from the time of the notification of the manufacturer:

202.1. an initial report of the manufacturer regarding the incident with the medical device shall be sent to the Agency within 10 days;

202.2. a report of the manufacturer regarding a potential incident with the medical device shall be sent to the Agency not later than within 30 days.

203. A manufacturer shall, after finishing the investigation of the incident, ensure the performance of the operations referred to in the opinion of the investigation of the incident and he or she has the right to receive justified explanations from the Agency regarding the operations performed (especially - if medical devices are withdrawn from the market).

204. A manufacturer shall, after finishing the investigation, draw up and transfer to the Agency the final report of the investigation. The final report of the investigation of the incident shall be a notification regarding the results obtained and the necessary operations co-ordinated.

205. A manufacturer shall ascertain that the procedures referred to in this Chapter are applied by the authorised representatives thereof or other persons who are jointly responsible for the placing on the market of the medical device and maintenance thereof and use of the vigilance system procedure.

206. A possessor or holder of a medical device shall, after sending of a signal report of the incident during the investigation of the incident in co-operation with the manufacturer of the medical device or the authorised representative thereof, continue to clarify the circumstances of the incident, inform the Agency regarding evidence obtained on regular basis and ensure free access to the referred to device, as well as to the documents of procurement, accounting, insurance, training, attestation, instructing and technical supervision, for the Agency or other experts, the manufacturer and representatives of the notified body.

[22 July 2008]

207. If an owner or holder of a medical device has doubts or if he or she does not agree with the results of investigation of the incident provided by the manufacturer, he or she has the right to invite independent experts or request repeated technical expert-examination of the medical device or article related to the incident.

208. The Agency shall develop and publish guidelines for the vigilance system procedures and operations and they shall be treated as recommendations.

209. In preparing the documents referred to in this Chapter and drafts thereof or in taking a decision regarding technical type to be applied for the dissemination of the documents, the confidentiality shall be observed. In selecting technical means for the notification of decisions and delivery of documents, the transfer of documents directly to the interested person shall be preferred (especially it applies to a user of the device or the management of the medical treatment institution).

210. If within the framework of the vigilance system any of the European Union Member States transfers at the disposal of the Agency a report of the incident regarding a malfunction or incident of the medical device of a particular model and series, which has caused damage to the health of a patient or caused the death of a patient, the Agency shall immediately notify the possessors or holders of the referred to medical device in the Republic of Latvia regarding a decision taken in relation to the use of the referred to device. In case of emergency, if serious threats to the public health exist, the Agency shall warn the public via mass media.

211. The Agency shall immediately notify a decision to the possessors or holders of such medical devices who have in their possession or holding medical devices of a particular model to which so far unknown risks to the health or life of a patient have been discovered anew or non-compliance to the newer or amended requirements of the standards has been proven.

212. The manufacturer, upon receipt of a report of the possessor or user, need not send an initial report of the incident to the Agency, if:

212.1. the user detects deficiencies prior to the commencement of use of the medical device and eliminates them immediately;

212.2. reliable information is at the disposal of the manufacturer that the incident is not directly related to the use of the medical device, but changes in status of health of the patient is related to the course of a clinical process. In such case the opinion of a medical practitioner and manufacturer regarding the incident, nature and outcome thereof shall match;

212.3. the reason of the incident is expiry of the term for storage or use of the device clearly specified by the manufacturer, and such terms have been clearly specified in the accompanying documents of the medical device;

212.4. the incident has been eliminated using a functioning signalling device of the medical device or other protective device manufactured in compliance with the determined standards and, therefore, risk to life of a patient has not been allowed;

212.5. the medical device is characterised by very low number of incidents. Especially it applies to a potential incident, where all risk factors are studied, assessed and identified as permissible due to their unimportant number;

212.6. expectable and foreseeable side-effects have been specified on the label of the medical device and in the instructions for use, specifying their functional and numerical expression which includes comparison of the possible benefit of a patient and potential risk to health when using a given medical device;

212.7. notes regarding identification of side-effects and risk analysis are available in the technical file of the manufacturer. The manufacturer is not entitled to assert that he or she has foreseen and notified risk assessment to the user, if the relevant notes are not at the disposal of the user; or

212.8. the incident has occurred when the manufacturer has already received a warning from the Agency in which certain requirements are included and the manufacturer is acting in accordance with them.

213. The Agency shall ensure the data protection of the information on surveillance of distribution of medical devices and vigilance system in compliance with the requirements of the Personal Data Protection Law, Commercial Law and Freedom of Information Law, insofar as it is not otherwise provided for in the legislation of the European Union in relation to medical devices.

213.1 The following information shall not be considered as confidential within the meaning of this Regulation:

213.11. data regarding registration of the persons who are responsible for placing on the market of medical devices;

213.12. information for users regarding medical device provided by the manufacturer, authorised representative or distributor; and

213.13. information included in the issued, corrected, suspended or revoked registration certificates.

[31 March 2009]

14. Closing Provisions

214. [22 July 2008]

215. [22 July 2008]

216. Until 1 January 2007 it is allowed to place on the market such medical devices incorporating, as an integral part, stable derivates of human blood or human plasma and which do not comply with the requirements of this Regulation. Such medical devices may be marketed and put into operation until 1 January 2009.

217. The owners of EC design-examination certificate or an EC type-examination certificate issued for the medical devices referred to in Paragraph 151 of this Regulation before 1 April 2004 shall ask the notified body additional EC design-examination certificate or an EC type-examination certificate which attests the compliance of the given medical devices with the technical requirements referred to in Annex to this Regulation.

[22 July 2008]

218. The following Regulations are repealed:

218.1. Cabinet Regulation No. 100 of 6 March 2001, Procedures for Registration, Sale and Distribution of Medical Devices and Medical Supplies; and

218.2. Cabinet Regulation No. 78 of 19 February 2002, Procedures for Operation and Technical Supervision of Medical Devices and Medical Supplies.

219. The manufacturer or the authorised representative thereof shall notify regarding Class IIb and Class III medical devices and medical devices of List A, List B and in vitro diagnostic medical devices for self-testing placed on the market in the Republic of Latvia before the day of coming into force of this Regulation in accordance with the notification procedure referred to in Paragraph 20 of this Regulation not later than by 1 January 2009.

[22 July 2008]

220. Hip, knee or shoulder joint replacements that have been subject to a conformity assessment procedure in accordance with Sub-paragraph 131.1 of this Regulation before 1 September 2007, shall be subject to a complementary assessment under Paragraphs 9, 10, 11, 12 and 13 of Annex 5 to this Regulation. Taking into account the results of examination, EC design-examination certificate shall be granted for hip, knee and shoulder joint replacements by 1 September 2009. This standard shall not preclude the manufacturer from submitting an application for conformity assessment in accordance with Sub-paragraphs 129.2 and 129.3 of this Regulation.

[22 July 2008]

221. Hip, knee or shoulder joint replacements for which EC design-examination certificate has been issued before 1 September 2007 in accordance with Sub-paragraph 131.1 of this Regulation may be placed on the market until 1 September 2009.

[22 July 2008]

222. Hip, knee and shoulder joint replacements that have been subject to a conformity assessment procedure in accordance with Sub-paragraph 131.4 of this Regulation before 1 September 2007 may be subject to a conformity assessment as class III medical devices in accordance with Sub-paragraph 129.2 or 129.3 of this Regulation before 1 September 2010. This standard shall not preclude the manufacturer from submitting an application for conformity assessment in accordance with Sub-paragraph 129.1 of this Regulation.

[22 July 2008]

223. Hip, knee or shoulder joint replacements for which EC design-examination certificate has been issued in accordance with Sub-paragraph 131.4 of this Regulation before 1 September 2007 and by which it is allowed to use such replacements before 1 September 2007 may be placed on the market and used by 1 September 2010.

[22 July 2008]

224. Breast implants which have been assessed in accordance with Sub-paragraph 131.1 or 131.4 of this Regulation and placed on the market before 2 August 2005 shall be subject to a conformity reassessment procedure as Class III medical devices.

[22 July 2008; 13 October 2009]

225. Paragraphs 171.1 and 171.2 of this Regulation shall come into force on 1 January 2009.

[22 July 2008]

226. Paragraph 173.1 of this Regulation shall come into force on 1 April 2010.

[22 July 2008]

Informative Reference to European Union Directives

[22 July 2008; 31 March 2009]

This Regulation contains legal norms arising from:

1) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices;

2) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices;

3) Council Directive 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits);

4) Directive 98/79/EC of the Council of 27 October 1998 on in vitro diagnostic medical devices;

5) Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma;

6) Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices;

7) Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices;

8) Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin;

9) Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices; and

10) Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.

Prime Minister A. Kalvītis

Minister for Health G. Bērziņš

 


Translation © 2006 Tulkošanas un terminoloģijas centrs (Translation and Terminology Centre)

 
Document information
Status:
No longer in force
no longer in force
Issuer: Cabinet of Ministers Type: regulation Document number: 581Adoption: 02.08.2005.Entry into force: 19.08.2005.End of validity: 01.12.2017.Publication: Latvijas Vēstnesis, 130, 18.08.2005.
Language:
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