Chapter One. Section I. General provisions

Transcription

1 LAW ON MEDICAL DEVICES In force from Published SG * No.46 of 12 June 2007 Chapter One GENERAL PRINCIPLES Section I. General provisions Article 1. (1) This Law shall regulate: 1. the conditions and procedure for placing on the market and/or putting into service of medical devices; 2. the obligations of the manufacturer, his authorised representative and the importer of medical devices; 3. the conditions and procedure for issuing of authorisations for conformity assessment of medical devices; 4. the conditions and procedure for conducting clinical tests of medical devices; 5. the conditions and procedure for performing wholesale trade in medical devices; 6. the surveillance of the market of medical devices; 7. the system for notification and assessment of incidents/potential incidents relating to medical devices. (2) The objective of this Law shall be to guarantee the placing on the market and/or putting into service of medical devices, which do not jeopardize the life and health of patients, medical specialists or third parties, whenever devices are used as intended and preserved, distributed, installed, implanted and maintained in accordance with the manufacturers instructions. Article 2. (1) According to the intended purpose specified by the manufacturer, the medical devices shall be classified as: 1. in vitro diagnostic medical devices; 2. active implantable medical devices; 3. medical devices, other than those specified in points 1 and 2. (2) The medical devices referred to in Paragraph 1, point 1, depending on the related potential risk, shall be classified in List A, List B and self-testing devices, and other groups, laid down in the ordinances referred to in Article 18. (3) The medical devices referred to in Paragraph 1, point 3, depending on the related potential risk shall be classified in classes I, IIа, IIb and III according to the classification rules laid down in the ordinances referred to in Article 18. (4) In case the manufacturer and the notified body, designated in compliance with * State Gazette

2 Chapter 4, have different opinions on the application of the classification rules referred to in Paragraph 3, the final decision shall be made by the Bulgarian Drug Agency (the BDA). (5) When necessity to bring the classification rules referred to in Paragraph 3 into line with the development of new technologies and/or with the information obtained in accordance with Chapter 7, the BDA shall draft the official state position tohether with reasoned request for undertaking the necessary measures, and shall submit it to the European Commission. Article 3. The requirements to the medical devices, laid down in this Law, shall apply also to: 1. accessories to these devices; 2. devices, which incorporate as an integral part a substance which, if used separately, may be considered medicinal product within the meaning of the Law on Drugs and Pharmacies in Human Medicine, and which impact on the organism is ancillary to the main intended use of the device; 3. devices, which incorporate as an integral part a substance derived from human blood or plasma, which, if used separately, may be considered component of medicinal product or medicinal product within the meaning of the Law on Drugs and Pharmacies in Human Medicine, and which impact on the organism is ancillary to the main intended use of the device; 4. devices, by means of which medicinal products are applied. Article 4. (1) In case that a product falls within the scope of this Law and of the ordinance referred to in Article 7 of the Law on the Technical Requirements to Products concerning personal protective equipment implementing Council Directive 89/686/EEC, the relevant general safety requirements laid down in the ordinance, shall apply to this product. (2) (In force from ) In case that a certain product falls within the scope of this Law and the provision referred to in Article 7 of the Law on the Technical Requirements to Products concerning machines, implementing Directive 2006/42/EC of the European Parliament and of the Council, the relevant essential safety requirements, laid down in the provision, shall be also applied to this product in the cases where these requirements are more specific than those laid down in the ordinance referred to in Article 18. Article 5. (1) This Law shall not apply to: 1. medicinal products within the meaning of the Law on Drugs and Pharmacies in Human Medicine; 2. medical devices, which are an integral part of medicinal products and are intended by the manufacturer for single use solely in this form; 3. cosmetic products within the meaning of the Law on Health; 4. organs, tissues or cells of human origin, intended for transplantation, as well as products, incorporating or derived from tissues or cells of human origin within the meaning of the Law on Transplantation of Organs, Tissues and Cells; 5. organs, tissues or cells of animal origin, intended for transplantation, unless the medical device is manufactured utilizing animal tissue which is rendered non- viable or nonviable products derived from animal tissue; 6. blood, blood components of human origin within the meaning of The Law on

3 Blood, Blood Donation and Blood Transfusion, as well as for devices, which at the time of placing on the market contain blood products, plasma or blood cells, with the exception of the medical devices referred to in Article 3, point 3; 7. medical devices referred to in Article 2, paragraph 1, point 1, which are not intended for placing on the market, and are used at the manufacture site, and if used at sites, located in proximity with the manufacture site, the ownership on them shall not be transferred to another legal person. (2) In the cases referred to in paragraph 1, point 2, the device must meet the requirements of the Law on Drugs and Pharmacies in Human Medicine. The essential requirements laid down in accordance of this Law shall only apply as regards the characteristics concerning the safe performance of the device. Article 6. In implementing its powers under this Law, the BDA shall: 1. register medical devices under the terms and conditions of Chapter Two; 2. issue authorisations for conducting clinical tests of medical devices; 3. issue authorisations or certificates for wholesale trade in medical devices; 4. implement surveillance of the medical devices placed on the market and/or put into service; 5. carry out control over the storage, wholesale trade, clinical tests and safety of the medical devices; 6. keep a system for registration and analysis of notifications for incidents with medical devices and undertake the relevant measures; 7. participate with its representatives in the Central Ethics Commission, established in accordance with the Law on Drugs and Pharmacies in Human Medicine; 8. submit information to the European database regarding the medical devices placed on the market and/or put into service; 9. participate in activities in the field of medical devices relating to the work of international bodies, organisations and agreements to which the Republic of Bulgaria is a party, as well as of the regulatory and control bodies of other states, and the organisations, working in the field of regulation of medical devices; 10. draw up and keep registers of medical devices, authorised clinical tests and issued authorisations or certificates for wholesale trade; 11. carry out other activities, provided for in this Law. Article 7. (1) For registration and issuing of certificate of registration, for issuing of authorisations and certificates in accordance with this Law, as well as registering modifications to them, fees shall be paid, based on a tariff, approved by the Council of Ministers. (2) Funds from the fees referred to in paragraph 1 and from the fines and pecuniary sanctions, imposed to natural and legal persons in accordance with this Law, shall be entered as a revenue of the budget of the BDA and the State Agency for Metrology and Technical Surveillance, in conformity with the activities referred to in paragraph 1 performed by them. Section II. Placing on the market and/or putting into service of medical devices

4 Article 8. (1) The medical devices shall be placed on the market and/or put into service when they meet the requirements of this Law and the implementing acts thereof. (2) The medical devices, with the exception of the custom-made, shall be placed on the market and/or put into service if they have the CE marking referred to in Article 15 affixed, certifying that conformity of the devices with the essential requirements has been assessed under the applicable conformity assessment procedures. Article 9. (1) The Executive director of the BDA shall issue an order for temporary suspension or prohibition for placing on the market and/or putting into service, and for withdrawal from the market of medical devices with affixed CE marking referred to in Article 15, as well as of custom-made devices, which may jeopardise the health and safety of patients, medical specialists or third parties, even if these are properly installed, maintained and used as intended. (2) The Bulgarian Drug Agency shall forthwith notify the order referred to in paragraph 1 to the European Commission, and the measures undertaken, stating the reasons for non-conformity of the devices with the requirements of this Law and the implementing acts thereof, which may be caused by: 1. failure to comply with the essential requirements, laid down in the ordinances referred to in Article 18; 2. improper application of the standards referred to in Article 13, paragraph 1; 3. shortcomings of the standards referred to in Article 13, paragraph 1. Article 10. (1) The person, responsible for placing on the market and/or for putting into service of medical devices, shall be the manufacturer. (2) In case that the manufacturer is not established in the territory of Member State or EEA State, he or she shall authorise in writing his/her representative, established in the territory of the European Union, hereinafter referred to as "authorised representative". Article 11. (1) The manufacturer of medical devices must design, develop, manufacture, pack and label them in conformity with the essential requirements, laid down in the ordinances referred to in Article 18, and to ensure their conformity assessment under the procedures applicable to them. (2) The conformity assessment referred to in paragraph 1, shall be carried out by the manufacturer or his/her authorised representative. (3) In case that the procedures, laid down in the ordinances referred to in Article 18, require the intervention by the notified body referred to in Article 64, paragraph 2, the manufacturer shall charge a notified body designated by him/her to perform, within the scope of its competence, the procedures applicable to the type of the device. (4) The manufacturer or his/her authorised representative, and the notified body referred to in paragraph 3, shall conclude a contract on the conditions, under which conformity assessment of the medical devices shall be carried out. (5) In the cases of manufacture of medical devices, where animal tissue which is rendered non-viable or non-viable products derived from animal tissue are used, prior to their conformity assessment referred to in paragraph 1, the manufacturer shall perform risk analysis and risk management while observing the requirements, laid down in the ordinances referred

5 to in Article 18. Article 12. (1) In the interest of the public health and upon reasoned request of either the Regional Inspectorate for Protection and Control of Public Health (RIPCPH), the National Centre for Public Health Issues or a medical establishment, the Minister of Health, in case of positive opinion of the Executive director of the BDA, may allow, as an exception and by way of an order, the putting into service of medical device, in the absence of the conditions referred to in Article 8. (2) Conditions and procedure for putting into service of devices referred to in paragraph 1, shall be laid down by way of an order of the Minister of Health. Article 13. (1) In case that the medical devices are designed and manufactured in conformity with national standards introducing the harmonised European standards, it may be considered that the devices meet the essential requirements, laid down in the ordinances referred to in Article 18. (2) In case that the medical devices referred to in Article 2, paragraph 1, point 3, are designed and manufactured in conformity with the official Pharmacopoeia in the Republic of Bulgaria, laid down in Article 12 of the Law on Drugs and Pharmacies in Human Medicine, it may be considered that the devices meet the essential requirements, laid down in the ordinances referred to in Article 18. (3) In case that the medical devices referred to in Article 2, paragraph 1, point 1 from List A, and if necessary also from List B, are designed and manufactured in conformity with general technical specifications, it may be considered that the devices meet the essential requirements, laid down in the ordinances referred to in Article 18. (4) In case that the manufacturer fails to meet the requirements of paragraph 3, he shall adopt technical solutions, by which equivalent result may be achieved. (5) Where it is found that the standards referred to in paragraph 1, do not cover completely the essential requirements, laid down in the ordinances referred to in Article 18, the BDA shall draw up and agree an official state position, which shall be submitted to the European Commission. Article 14. (1) The manufacturer of medical devices shall draw up technical documentation, which content is specified in the relevant ordinances referred to in Article 18. (2) Following the implementation of the applicable conformity assessment procedures, the manufacturer or his/her authorised representative shall draw up a declaration of conformity of the medical device. (3) The manufacturer or his/her authorised representative must keep the technical documentation referred to in paragraph 1, and the declaration of conformity referred to in paragraph 2, for at least 5 years from the date of temporary suspension of the medical device s manufacture and must submit them upon request for inspection by the persons referred to in Article 86, paragraph 2. Article 15. (1) The CE marking with graphics according to the Annex, which is shall be affixed on the medical device before its placing on the market and/or putting into service, must appear in a visible, legible and indelible form.

6 (2) The CE marking must be affixed on a visible part of the device, the instructions for use and on its sterile packaging, if any. Where possible, it shall be affixed also on the sales packaging. (3) The CE marking must have a vertical dimension at least 5 mm, unless otherwise provided for in the relevant ordinance referred to in Article 18. In case that the CE marking is reduced or enlarged, the proportions given in the graduated drawing, must be respected. (4) Next to the CE marking referred to in paragraph 1 the identification number of the notified body shall be affixed in the cases referred to in Article 11, paragraph 3. (5) The CE marking and the identification number referred to in paragraph 4, may not be affixed on the device only when the form and dimensions of the device do not allow it. (6) Any other marking, which shall be affixed on the device, its packaging and/or its instructions for use, must not mislead the user - medical specialist or patient, regarding the marking referred to in paragraph 1, and must not damage its visibility and legibility. (7) In case of devices, which shall be placed on the market in sterile packaging, the CE marking shall be affixed both on the sterile and the sales packaging of the device. (8) In case of complete remodelling of the device, which is likely to affect its safe use, the CE marking shall be affixed after reassessment of the device according to the applicable procedures, set out in the ordinances referred to in Article 18. (9) In case the medical device falls within the scope of Article 7 of the Law on the Technical Requirements to Products, providing for an affixing of CE marking, the marking shall certify the conformity of the device with the requirements of each ordinance, unless otherwise provided for in those ordinances. (10) Medical devices without affixed CE marking may be displayed at exhibitions, fairs, demonstrations, promotions, scientific and technical conferences. (11) In the cases referred to in paragraph 10 the manufacturer shall affix on the devices a visible designation, unequivocally stating that devices are not intended for placing on the market and/or for putting into service. Article 16. (1) The manufacturer of medical devices must indicate on the device its packaging and instructions for use its name and address. Instruction for use may not be required for the devices referred to in Article 2, paragraph 1, point 3 of class I and IIа, which, in the opinion of the manufacturer, may be used safely without instruction for use. (2) The packaging and the instructions for use of devices, imported from third countries on the territory of the European Union or on the EEA territory, must bear also the name and address of the authorised representative and of the importer. (3) The instructions for use must be drawn up in Bulgarian language as well. Article 17. The manufacturer or his authorised representative must ensure the safe installation of the medical devices on the territory of the Republic of Bulgaria, in case that their specific requires so according to the instructions for use, and to provide the maintenance thereof. Article 18. The Council of Ministers, at the suggestion of the Minister of Health and of the Minister of Economy and Energy, shall draw up, for the medical devices referred to in Article 2, paragraph 1, ordinances on:

7 1. the essential requirements; 2. the procedures for assessment the conformity with the essential requirements and the content of the technical documentation; 3. the classification rules of the medical devices referred to in Article 2, paragraph 1, point 3; 4. the lists, covering the scope of the groups of in vitro diagnostic medical devices; 5. the requirements for conducting risk analysis and for risk management for the medical devices, referred to in Article 11, paragraph 5. Section III. Placing on the market and/or putting into service of medical custommade devices Article 19. (1) The manufacturer or his authorised representative, before placing on the market and/or putting into service of the medical device referred to in Article 2, paragraph 1, point 2 or 3, which is custom-made, shall draw up a documentation, containing: 1. identification data of the device; 2. declaration, that the medical device is intended for special use from a particular patient, whose name is indicated; 3. the name of the physician or the dental therapist, who made out the assignment for manufacture of the device, and where possible, the name of the medical establishment; 4. the characteristics of the medical device according to the assignment; 5. declaration that the device conforms with the applicable essential requirements. (2) In case that the device does not meet any of the applicable essential requirements, the non-conformity shall be justified in the declaration referred to in paragraph 1, point 5. (3) The documentation referred to in paragraph 1, shall be kept by the manufacturer or by his authorised representative for at least 5 years. (4) The manufacturer of custom-made devices referred to in Article 2, paragraph 1, point 3, shall submit, upon request from the BDA, a list of devices put into service on the territory of the Republic of Bulgaria. Article 20. (1) The manufacturer shall draw up the technical documentation referred to in Article 14, paragraph 1, and shall submit it upon request for inspection to the persons referred to in Article 86, paragraph 2. (2) The manufacturer must undertake the necessary measures in order to provide, through the manufacturing process, the conformity of the devices referred to in Article 19, with the documentation referred to in paragraph 1. Section IV. Placing on the market of systems or sets medical devices Article 21. (1) Natural or legal person, who makes up a set of medical devices referred to in Article 2, paragraph 1, point 3, with affixed CE marking, before placing them

8 on the market as a system or a set, shall draw up declaration, stating that he: 1. has made up the system or the set according to intended use of the detached devices and their restrictions for use, specified by the manufacturers; 2. has checked the conformity of the detached medical devices and has carried out the operations for making up sets in accordance with the manufacturers instructions; 3. has packed the system or the set and has submitted the relevant information to the users, including the relevant manufacturers instructions; 4. his activity is subject of appropriate procedures for internal control and inspection. (2) In case any of the requirements of paragraph 1 is not fulfilled, the system or the set is subject of conformity assessment with the essential requirements, laid down in the ordinances referred to in Article 18. Article 22. (1) Natural or legal person, who sterilize the systems or sets of medical devices referred to in Article 21, and/or the medical devices referred to in Article 2, paragraph 1, point 3, with affixed CE marking, intended by the manufacturer to be sterilized before use in order to place them on the market, must assess the conformity thereof, following the procedures, set out in the relevant ordinances referred to in Article 18. (2) Application of the procedures referred to in paragraph 1, and the actions of the notified body shall be restricted up to meeting the sterility requirements. (3) The person referred to in paragraph 1, shall draw up declaration according to the requirements, provided for in the relevant ordinance that sterilisation was made in accordance with the manufacturers instructions. Article 23. The persons referred to in Article 21, paragraph 1 and Article 22, paragraph 1, shall keep the declarations for at least 5 years from the date of manufacture and shall submit them, upon request for inspection, to the persons referred to in Article 86, Paragraph2. Article 24. The systems or sets of medical devices referred to in Article 21, the sterilized systems or sets, and the medical devices referred to in Article 2, paragraph 1, point 3, with affixed CE marking, intended by the manufacturer to be sterilized before use, shall be placed on the market without additional CE marking, accompanied by instruction for use, which shall include, where appropriate, the information, submitted by the manufacturers of the detached devices of the system or the set, the requirements they should meet according to the relevant ordinance referred to in Article 18. Section V. Performance assessment of in vitro diagnostic medical devices Article 25. (1) Conformity assessment of in vitro diagnostic medical devices with their special purpose under conditions of use, specified by the manufacturer, shall be carried out by performance assessment based on: 1. compiled data from the scientific literature, related to the intended use of the device, and critical analysis of this data, and/or

9 2. the results from the tests of performance assessment or other appropriate tests. (2) The manufacturer or his authorised representative, before submitting in vitro diagnostic medical devices for performance assessment in accredited laboratory, shall draw up documentation containing: 1. identification data of the device; 2. assessment plan, comprising of the objective, the scientific, technical or medical grounds, assessment scope and quantity of devices; 3. list of the accredited laboratories, which participate in the assessment; 4. starting date and intended duration of the assessment; 5. for self-testing devices place and number of the persons without medical qualification, who participate in the assessment; 6. declaration that the medical device conforms to the applicable essential requirements, with the exception of those which are subject of performance assessment and which are explicitly specified, and that all precautions, necessary for protection the health and safety of the medical specialists, of the patients or of third parties, have been taken. Article 26. (1) The manufacturer shall draw up the technical documentation referred to in Article 14, paragraph 1, and shall submit it for inspection upon request to the persons referred to in Article 86, paragraph 2. (2) The manufacturer must undertake the necessary measures in order to ensure, through the manufacturing process, the conformity of in vitro diagnostic medical devices for performance assessment, to the documentation referred to in paragraph 1. Chapter Two REGISTRATION OF MEDICAL DEVICES Article 27. (1) In case that the manufacturer of medical devices of class I, referred to in Article 2, paragraph 1, point 3, the manufacturer of custom-made devices referred to in Article 2, paragraph 1, point 3, as well as the natural or legal person referred to in Article 21, paragraph 1 and Article 22, paragraph 1, are registered under the Commercial Law, they shall submit an application for registration according to a model form to the Executive director of the BDA not later than 14 days after placing on the market and/or putting into service of the device on the territory of the Republic of Bulgaria. (2) The application for registration referred to in paragraph 1 shall be accompanied by: 1. current certificate for entry in the Commercial Register; 2. name and description of the device; 3. fee paid receipt according to the tariff referred to in Article 7, paragraph 1. (3) The persons referred to in paragraph 1 and 4 must notify the Executive director of the BDA within 14 days period about any change in their business address. In case a change in the information referred to in paragraph 2, point 2, has occurred, the persons referred to in paragraph 1 and 4, shall submit to the Executive director of the BDA the application referred to in paragraph 1, enclosing all documents, related to the change, and the fee paid receipt according to the tariff referred to in Article 7, paragraph 1.

10 (4) The manufacturers of devices referred to in paragraph 1, established on the territory of another Member State or EEA State, who are not registered for the same devices by a regulatory body of the Member State concerned, or by the regulatory body of EEA State concerned, shall submit an application to the BDA, accompanied by the documentation referred to in paragraph 2, points 2 and 3, and by a document for current registration as a trader pursuant to the national legislation of the state concerned, not later than 14 days after placing on the market and/or putting into service of the device on the territory of the Republic of Bulgaria. Article 28. (1) In case that the manufacturer of devices referred to in Article 2, paragraph 1, point 1 shall, on his behalf, place on the market and/or put into service on the territory of the Republic of Bulgaria these devices and is registered under the Commercial Law, he shall submit an application for registration according to a model form to the Executive director of the BDA. (2) The application for registration referred to in paragraph 1 shall be accompanied by: 1. current certificate for entry in the Commercial Register; 2. information for the general technological and/or analytical characteristics, related to the reagents, reagent products, calibrators and control materials; 3. in case of devices from Lists А, B and self-testing devices - name, type and model of the device, analytical parameters, and where appropriate, diagnostic parameters as regards the essential requirements, set out in the ordinances referred to in Article 18, and results from the performance assessment under Chapter One, section V; 4. instruction for use in Bulgarian language; 5. fee paid receipt according to the tariff referred to in Article 7, paragraph 1. (3) The manufacturer who shall, on his behalf, place on the market and/or put into service on the territory of the Republic of Bulgaria new diagnostic medical device in vitro, and is registered under the Commercial Law, shall submit to the BDA the documentation referred to in paragraph 2, as well as indication that the device is a new one. (4) In vitro medical device shall be considered as new one, in case on the market of the Member State or of the EEA State during the last three years: 1. such device has not constantly been available for the analyzed substances or other parameters, or 2. analytic technology, used for the analyzed substances or parameters, has not been available. (5) Manufacturers of devices referred to in paragraphs 1 and 3, established in the territory of another Member State or EEA State, who are not registered for the same devices from a regulatory body of the Member State concerned or from a regulatory body of the EEA State concerned, shall submit to the BDA an application, accompanied by the documentation referred to in paragraph 2, point 2 5, and by a document for current registration as a trader under the national legislation of the state concerned, after placing on the market and/or putting into service of the device on their behalf on the territory of the Republic of Bulgaria. (6) The application for registration referred to in paragraphs 1, 3 and 5, shall be submitted within 14 days period from the date of placing on the market and/or putting into service of devices referred to in Article 2, paragraph 1, point 1. (7) The persons referred to in paragraph 1, 3 and 5, must notify within 14 days period

11 the Executive director of the BDA in case of: 1. change in the business address; 2. significant changes in the information referred to in paragraph 2, points 2 and 3; 3. changes in the certificates, issued under the procedures, applicable for the device, according to the relevant ordinance referred to in Article 18; 4. withdrawal of the device from the market. Article 29. (1) Manufacturers of devices referred to in Article 27 and 28, and the persons referred to in Article 21, paragraph 1 and Article 22, paragraph 1, in case that they are established in the territory of another Member State or of EEA State and are registered for the same devices from regulatory body of the Member State concerned or from a regulatory body of the EEA State concerned, shall submit notification according to a model form to the BDA within 14 days from placing on the market and/or putting into service of these devices on the territory of the Republic of Bulgaria. (2) In case manufacturers of devices referred to in Article 27 and 28, and the persons referred to in Article 21, paragraph 1 and Article 22, paragraph 1 are not established in the territory of a Member State or EEA State, but are registered for these devices from regulatory body of a Member State or from regulatory body of EEA State by authorised person(s), they shall submit notification according to a model form to the BDA within 14 days from placing on the market and/or putting into service of these devices on the territory of the Republic of Bulgaria. (3) In case manufacturers of devices referred to in Article 27 and 28, and the persons referred to in Article 21, Paragraph1 and Article 22, Paragraph1, are not established in the territory of another Member State or EEA State, and are not registered for these devices from regulatory body of the Member State concerned or from a regulatory body of the EEA State concerned, they shall authorize persons, registered under the Commercial Law, who place these medical devices on the territory of the Republic of Bulgaria. (4) The authorised persons referred to in Paragraph3, shall submit to the BDA an application for registration according to a model form in accordance with Article 27 and 28. (5) The authorised person referred to in Paragraph3, shall notify the BDA for any change in his business address. Article 30. The manufacturer of devices referred to in Article 2, paragraph 1, point 2 and 3 of class IIb or III, shall, upon request, submit to the BDA information about the name, type, model and class, label and instruction for use in Bulgarian language of all devices put into service on the territory of the Republic of Bulgaria. Article 31. (1) The Bulgarian Drug Agency shall keep a register of all medical devices placed on the market and/or put into service referred to in Articles 27, 28 and 29. (2) The register referred to in Paragraph1, shall contain: 1. number and date of registration; 2. name, type, class and expiry date of the medical device; 3. name and business address of the person, who shall place on the market and/or put into service the medical device; 4. date of elimination of the medical device from the register and the reason for that;

12 5. notes relating to the circumstances entered. (3) The Bulgarian Drug Agency shall submit registration data of devices referred to in Articles 27, 28 and 30, upon request from the regulatory bodies of other Member States and of the European Commission. Chapter Three CLINICAL TESTS OF MEDICAL DEVICES Section I. General provisions Article 32. Conformity assessment of the medical devices referred to in Article 2, Paragraph1, point 2 and 3, with their specific purpose under conditions of use, the risk assessment, referred to the intended use of the device, and the risk assessment for incident or potential incident, shall be carried out on the grounds of clinical data, based on: 1. compiled data from the scientific literature, related to intended use of the device, and critical analysis of this data, and/or 2. the results from the from clinical tests conducted. Article 33. Clinical test shall be conducted in medical establishments within the meaning of the Law on Medical Establishments. Article 34. (1) The clinical test with devices referred to in Article 32, shall be conducted observing the main principles that guarantee the rights, safety, health and human dignity of the participants in the test, laid down in the Helsinki Declaration for the ethical principles for conducting clinical tests on human subjects. (2) The rights, safety and health of the participants in the clinical test must take precedence over the interests of science and society. (3) The clinical test shall be initiated and conducted, provided the foreseen benefits for the participant and for the society justify the risks. (4) The clinical test must be planned in such a way as to minimise discomfort, pain, fear and other foreseen risks related to the disease, and the risk threshold and degree of physical pain to be determined beforehand and to be a subject of permanent control during the test. (5) Granting financial or other incentives for recruiting participants in the clinical test, other than compensations (transport cost, allowances, etc.), shall not be allowed. Article 35. (1) The clinical test must involve sufficient number of observations in order to ensure scientific reliability of the conclusions. (2) The procedures for conducting the clinical test must be appropriate for the investigated device. (3) The clinical test shall be conducted in conditions, similar to the normal conditions

13 of use of the device. (4) The clinical test must cover all characteristics of the device, relating to its safety and performance, and its effect on the participants. Article 36. (1) All the information of the clinical test shall be recorded, handled and stored in such a way as to ensure the reporting, interpretation and verification thereof. Personal data of the participants in the clinical test shall be stored according to the Law on Protection of the Personal Data. (2) The documentation referred to in paragraph 1, shall be kept by the Chief researcher or the coordinating researcher for a period of 20 years from the date of finishing the clinical test and shall be submitted upon request to the relevant Ethics Commission (s) and to the BDA. Article 37. (1) Clinical test of devices referred to in Article 32, shall be allowed only for a person: 1. who received beforehand a written information about the nature, significance, consequences and possible risks of the clinical test, and in discussion with a physician or a dental therapist member of the test team, he received explanation for the objectives, risks, inconveniences of the test and the conditions under which it will be conducted; 2. who was informed about his right to refuse the test at any time, without any negative consequences for him; 3. who gave personally a written informed consent for participation. (2) In case the person shall not be able to express a written consent, he may give a verbal consent in presence of an independent witness. The witness shall certify in writing that the person has expressed personally an informed consent for participation in the clinical test. (3) Only an able person, who understands the nature, significance, consequences and possible risks from the clinical test, may give the informed consent referred to in paragraph 1, point 3 and paragraph 2. The informed consent for participation in clinical test may be revoked at any time without any negative consequences for the person. (4) The clinical test on a less able person of full age may be performed after receiving a written informed consent from the person and from his legal representative. The less able person of full age must receive the information referred to in paragraph 1, point 1, in accordance with his ability for understanding. His/her explicit wish to withdraw from the clinical test at any time must be taken into account by the researcher, and where appropriate by the Chief researcher. (5) Informed consent for an adult disable person may be given by his/her legal representative. (6) In the cases referred to in Article 162, paragraph 3 of the Law on Health, informed consent shall by given by a person, appointed by the court. Article 38. (1) The clinical test on a minor person may be performed after receiving a written informed consent from his/her legal representatives the two parents or the person s guardian, observing the requirements of Article 37, paragraph 1, points 1 and 2, and paragraph 3. In case one of the parents is unknown, deceased or deprived of parent s rights, or is not granted custody in the cases of divorce, the parent who exercises the parental rights shall give

14 the written informed consent. (2) The clinical test on an underage person may be performed after receiving of a written informed consent from the person and his legal representatives - the two parents, or from the person s guardian, observing the requirements of Article 37, Paragraph1, point 1 and 2 and Paragraph3. In case one of the parents is unidentified, deceased or deprived of custody, or such rights are not delegated in the cases of divorce, the underage person and the parent who exercises the parental rights shall give a written informed consent. (3) The minor or underage person must receive, in an understandable manner suitable for him/her, information about the nature, significance, consequences, possible risks and benefits from the clinical test from a physician with recognised specialty on infantile disorders or from an infantile psychologist. (4) The consent of the parents or the guardian must represent the presumable will of the minor person and may be withdrawn at any time during conduction of the clinical test, without any negative consequences for the minor and/or for them. (5) The consent of an underage person and of the parents or of the trustee may be withdrawn at any time during the conducting of the clinical test, without any negative consequences for them. Article 39. Decision for participation in clinical test of a minor, underage, incapable or an adult with limited capability, when an informed consent from the parent(s) or from the guardian or the trustee cannot be taken as a matter of urgency, and when the immediate aim is rescuing his/her life, shall be taken by at least two physicians, independent both from the assignor and from the Chief researcher or the coordinating researcher. Article 40. (1) Clinical test on pregnant women may be undertaken and shall be conducted observing the requirements of Article 37 only in the cases, where there are no other proven alternative methods for performing of diagnostics or treatment, and in case it does not compromise the life and health of the pregnant woman and the foetal viability. (2) Decision for participation in clinical test in the cases referred to in Paragraph1, shall be taken by a medical commission, consisting of specialists, independent from the assignor and from the Chief /coordinating researcher. Article 41. (1) During the test the participant shall receive upon request additional information from a person, independent from the assignor. (2) The written information, submitted to the participants in clinical test, shall contain contact details of the independent person referred to in paragraph 1. Article 42. (1) In case of conducting of one-centre or multi-centre clinical test on the territory of the Republic of Bulgaria, where the assignor is not established in the territory of the European Union or on the territory of EEA State, he shall authorise a representative of him/her, established in the territory of the Republic of Bulgaria. (2) In case of conducting of multi-centre clinical test on the territory of the Republic of Bulgaria, on the territory of other Member State(s), EEA State(s) and/or on the territory of a third country, where the assignor is not established in the territory of the European Union, he shall authorize a representative of him/her, established in the territory of a Member State or

15 EEA State. (3) The authorised representative referred to in paragraphs 1 or 2, shall bear the responsibility for conducting the clinical test on the territory of the Republic of Bulgaria, in accordance with the legislation in force. (4) The clinical test shall be conducted under the management of a researcher, who shall be: 1. physician or dental therapist with qualification in the scope of application of the device and specifically trained for work with the investigated device; 2. acquainted with the methods and the requirements for conducting the clinical test; 3. acquainted with the principles and the requirements for receiving an informed consent. (5) The researcher team must hold the relevant qualification and experience, and should have passed the relevant training for performing the tasks related to the test. (6) Control over the clinical test shall be performed from the assignor or from his authorised representative, or from a person, appointed by him an observer. (7) During the clinical test the physician, respectively the dental therapist shall follow the health status of the participant, and shall, if necessary, undertake the relevant medical measures. Article 43. Planning, conducting, monitoring and reporting the results of the clinical test, as well as the obligations of the assignor, of the Chief researcher or the coordinating researcher and of the observer, should meet the requirements of this Law and should be in conformity with the requirements of the standards ISO and ISO Article 44. (1) The assignor and the Chief researcher or the coordinating researcher shall conclude an insurance contract, covering their responsibilities for the non-pecuniary and pecuniary damages, caused to the participants at the time or due to conducting the clinical test. (2) The assignor shall bear responsibility in case of deterioration in the state of health or of decease, caused at the time or due to conducting the clinical test, in case that the requirements and the procedures of the plan, approved by the Ethics Commission, are met. (3) The Chief researcher or the coordinating researcher shall bear responsibility in case of deterioration in the state of health or of decease, caused at the time or due to conducting the clinical test, in case that the requirements and the procedures of the plan, approved by the Ethics Commission, are not met. Section II. Authorisation for conducting clinical test Article 45. (1) Clinical tests of medical devices referred to in Article 2, paragraph 1, point 3 of class III, of implantable medical devices and of invasive medical devices for longterm use referred to in Article 2, paragraph 1, point 3, of class IIа or IIb, and of the devices referred to in Article 2, paragraph 1, point 2, which shall be conducted on the territory of the Republic of Bulgaria, may initiate after receiving of a positive opinion from the Ethics Commission for multi-centre tests or from the Ethics Commission of the medical

16 establishment concerned, which commissions are established under the Law on Drugs and Pharmacies in Human Medicine, and receiving of authorisation from the Executive director of the BDA. (2) Clinical tests of medical devices, other than those referred to in paragraph 1, which shall be conducted on the territory of the Republic of Bulgaria, may start after notification to the Executive director of the BDA, if the Ethics Commission referred to in paragraph 1, has delivered a positive opinion. (3) Provisions of paragraphs 1 and 2 shall apply also to medical devices with affixed CE marking, in case that the clinical tests are to be conducted for the purpose of changing their intended use. Article 46. The assignor or the Chief researcher or the coordinating researcher may submit an application for notification or authorisation for conducting a clinical test, to the Ethics Commission concerned, and to the BDA, simultaneously or consecutively. Article 47. (1) In case of multi-centre clinical test on the territory of the Republic of Bulgaria, the persons referred to in Article 46 shall submit an application to the Ethics Commission for multi-centre tests. (2) In case of one-centre clinical test on the territory of the Republic of Bulgaria, the persons referred to in Article 46 may submit an application to the Ethics Commission for multi-centre tests or to the Ethics Commission, established in the medical establishment concerned. Article 48. (1) In order to receive an opinion from the Ethics Commission concerned, the Chief/coordinating researcher or the assignor, shall submit: 1. administrative documentation; 2. information for the participant; 3. documentation for the test plan; 4. documentation for the tested medical device; 5. documentation for the technical capabilities of the medical establishment and professional qualification of the test team; 6. source of funding and administrative organisation of the test. (2) The content of the documentation referred to in paragraph 1, shall be specified in an order of the Minister of Health. (3) In case the Ethics Commission finds that the documentation referred to in paragraph 1 is incomplete, it shall notify the applicant within 14 days and shall fix a time for eliminating the shortcomings. (4) The Ethics Commission shall draw up an opinion within 30 days from submission of the valid documentation, and shall submit it to the assignor and to the BDA. Article 49. (1) In case the opinion of the Ethics Commission referred to in Article 48 is unfavourable, the assignor may, within 14 days from the date of notification, appeal the decision at the Central Ethics Commission, established under the Law on Drugs and Pharmacies in Human Medicine. (2) The Central Ethics Commission must deliver a decision within 14 days from the

17 date of receiving the written appeal from the assignor. (3) Decision of the Central Ethics Commission shall be final and binding for the Ethics Commission. Article 50. (1) For receiving an authorisation for conducting the clinical test referred to in Article 45, Paragraph1, the assignor shall submit to the BDA an application according to a model form. (2) The application referred to in Paragraph1, shall be submitted not later than 60 days before the date of starting the test, and shall be accompanied by the following documentation: 1. identification data for the medical device in both paper and electronic format; 2. clinical test plan, containing the objective, the scientific, technical and medical reasons for its conducting, the scope, methodology and organization of the test and number of the devices; 3. names of the researchers, Chief researcher(s) or of the coordinating researcher, as well as the name and address of the medical establishments, where the clinical test shall be conducted; 4. starting date, final date and timetable for performing the tests; 5. positive opinion from the Ethics Commission, in case the assignor has consecutively submitted the applications referred to in Article 46; 6. declaration that the medical device meets the applicable essential requirements, with the exception of those, which are subject of the clinical test, and that all precautions necessary for protection the health and safety of the participants in the test and of test team, have been ensured; 7. insurance contract, covering the responsibilities of the researcher and of the assignor for the non-pecuniary and pecuniary damages, caused to the participants at the time or due to conducting the clinical test; 8. draft contract between the assignor and the medical establishment; 9. fee paid receipt according to the tariff referred to in Article 7, paragraph 1. (3) In case of simultaneous submission of the applications referred to in Article 46, the assignor may submit the opinion referred to in paragraph 2, point 5, after he receives it, but not later than the term specified in Article 51, paragraph 1. (4) The assignor shall declare that the documentation submitted to both the BDA and to the Ethics Commission, is identical. Article 51. (1) The Bulgarian Drug Agency shall assess the submitted documentation referred to in Article 50, within 60 days from the date of receipt thereof. (2) The Bulgarian Drug Agency may require further information, related to the documentation referred to in Article 50, paragraph 2. (3) In the cases referred to in paragraph 2, the 60 days period of time shall be ceased until submission of the required documentation. (4) The Executive director of the BDA, within the term under paragraph 1, shall notify in writing the assignor that: 1. he/she authorises the conducting of the clinical test, or 2. the test may not be conducted, specifying the reasons for refusal. (5) In the cases referred to in paragraph 4, point 2, the assignor may, within 30 days

18 from the date of notification, submit to the BDA an application, revised in conformity with the reasons stated for refusal of the clinical test. (6) Within 30 days from the date of submission of the revised application referred to in paragraph 5, the BDA shall notify in writing the assignor that: 1. he/she authorises the conducting of the clinical test, or 2. test may not be conducted, specifying the reasons for refusal. (7) Copy of the authorisation for conducting the clinical test shall be sent to the medical establishment, specified in the application referred to in Article 50, paragraph 1. (8) In case the term referred to in paragraph 1 has not been observed, the assignor may start the test right away. Article 52. (1) The Executive director of the BDA shall refuse issuing of authorisation for conducting of clinical test on the territory of the Republic of Bulgaria, stating the grounds for that, in case that: 1. sufficient evidence for the anticipated scientific and medical benefits of the medical device s use have not been submitted; 2. persuasive evidence for the safety of the participants in the test and/or of test team has not been submitted; 3. the submitted information for assessment safety of the clinical test is incomplete; 4. performance of the device does not correspond to the intended use, specified by the manufacturer. (2) Refusal referred to in paragraph 1, shall be subject of appeal in accordance with the Administrative Procedure Code. (3) In case of multi-centre test, the BDA shall notify the refusal referred to in Paragraph 1 to the regulatory bodies of the other countries and shall state the grounds for that. Article 53. (1) The assignor may, at any time, introduce changes other than the essential changes in the clinical test plan. (2) In the cases referred to in paragraph 1 the assignor shall keep the documentation, related to the changes, and shall submit it to the BDA and of the Ethics Commission concerned. Article 54. (1) The assignor may apply planned essential changes in the clinical test plan. (2) In the cases referred to in paragraph 1, the assignor shall submit an application, accompanied by documentation, related to the changes, to the Ethics Commission concerned and to the BDA. (3) The Ethics Commission, within 15 days from receipt of the application referred to in paragraph 2, shall draw up an opinion and shall submit it to the assignor and to the BDA. (4) Within 15 days from the date of receipt of opinion from the Ethics Commission concerned, the Executive director of the BDA shall: 1. issue supplement to the authorisation for carrying out the test, by which he shall approve the change of the plan, or 2. refuse the essential change referred to in Paragraph1, stating the grounds for that. (5) Refusal referred to in Paragraph4, point 2, shall not be subject of appeal.

19 (6) In case that the applicant does not receive a refusal from the BDA within the term referred to in Paragraph4, he may carry out the clinical test according to the changed plan. Article 55. (1) Provided new circumstances occur, which may compromise safety of the participants in the clinical test during its conducting, the assignor and the researcher shall undertake emergency measures for their protection against the risks unexpectedly occurred. (2) In the cases referred to in Paragraph1, the assignor may do changes in the clinical test plan. (3) The assignor shall forthwith notify the Ethics Commission concerned and the BDA for the measures undertaken, the reasons for them and for the changes in the plan. Article 56. (1) The assignor of the clinical test must submit to the BDA upon request, a technical documentation, containing: 1. design drawings, methods of manufacture, including with respect to the sterilization, diagrams of components and sub-assemblies, connection diagrams, etc.; 2. descriptions and explanations necessary to understand the abovementioned drawings and diagrams, and the operations of the medical device; 3. the results of the risk analysis and a list of the standards referred to in Article 13, Paragraph1, applied in full or in part, and descriptions of the technical solutions adopted to meet the essential requirements, in case that the standards have not been applied at all, or have not been applied in full; 4. the results of the design calculations and of the inspections and technical checks carried out. (2) The assignor of the clinical test must keep the technical documentation for 10 years after conducting the clinical test for the devices referred to in Article 2, Paragraph1, point 2, and for 5 years - for the devices referred to in Article 2, Paragraph1, points 1 and 3. (3) The manufacturer must ensure a manufacturing process under which the medical devices, intended for clinical test, shall be manufactured in conformity with the technical documentation. Article 57. (1) Within 90 days after the end of the clinical test, the assignor shall submit to the BDA and of the Ethics Commission concerned a final report, containing descriptions of the methodology and organization, critical assessment and statistical analysis of the data obtained. (2) The report referred to in Paragraph1, shall be signed by the assignor and by all researchers. In case that any of the researchers refuses to sign it, he shall give his reasons in writing. (3) The report referred to in Paragraph1 shall summarize the data, obtained in all medical establishments and from all participants in the test. (4) Personal data of the participants in the test, stated in the report referred to in Paragraph1, must be encrypted. Article 58. (1) The Bulgarian Drug Agency shall keep a register of the issued and withdrawn authorisations for conducting clinical tests. (2) The Bulgarian Drug Agency shall organize and create a system for registration,

20 analysis and summary of incidents with medical devices during conducting clinical tests. (3) Procedure for tracing the safety of the medical devices during the clinical test shall be determined under the ordinance referred to in Article 48, paragraph 2. Article 59. (1) The Executive director of the BDA may, by way of an order, suspend or terminate the carrying out of the test if: 1. the test is performed under conditions, other than those specified in the authorisation; 2. there is an information for vitiating the scientific validity of the test; 3. risk for the safety of participants exists. (2) Prior to undertaking the actions referred to in Paragraph1, the BDA shall notify its intentions in writing to: 1. the assignor and the coordinating researcher, responsible for carrying out the test in all medical establishments, or 2. the assignor and the Chief researcher, responsible for the medical establishment concerned, in case the test should be suspended. (3) Within 7 days from the notification referred to in paragraph 2, the assignor or the Chief researcher or the coordinating researcher may submit written explanations to the BDA. (4) Paragraph 2 shall not be applied if immediate risk for the health and safety of the participants in the test exists. (5) The ordinance referred to in paragraph 1, may be appealed in accordance with Administrative Procedure Code, as appeal shall not stop the conducting. (6) The Chief researcher or the coordinating researcher shall notify the participants in the clinical test for the ordinance referred to in paragraph 1. Article 60. In the cases referred to in Article 59, paragraph 1, the Executive director of the BDA shall forthwith notify: 1. the regulatory bodies of the Member States; 2. the relevant Ethics Commissions; 3. the European Commission. Chapter Four NOTIFIED BODIES Article 61. (1) Authorisation for performing of conformity assessment of medical devices shall be issued to a natural or legal person, registered under the Commercial Law, by the president of the State Agency for Metrology and Technical Surveillance. (2) The person referred to in paragraph 1, shall submit to the president of the State Agency for Metrology and Technical Surveillance a written application, specifying the devices and the procedures for which he or she applied. (3) The application referred to in paragraph 2, shall be accompanied by: 1. certificate referred to in Article 33 of Law on the Commercial Register, if the person is registered under the Commercial Law, or a copy of the establishment act if the

21 person is established by a law or an act of the Council of Ministers; 2. certificate that the person has not been declared insolvent or is not under procedure for declaring insolvent; 3. documents certifying that the person has no liabilities to the state or to any municipality within the meaning of the Tax-Insurance Procedure Code, ascertained by statement in force, issued by a competent authority, or liabilities to insurance funds, unless the competent authority has approved a respite or reprieve of the liabilities; 4. copies of employment and/or civil (short-term) contracts of the personnel, documents for education, additionally awarded qualification; 5. copy of the contract, in case that the person participate in unions of companies or organizations; 6. copies of the contracts with the subcontractors, in case that examinations and tests were subcontracted; 7. copy of the contract for insurance, which covers the risk of implementation the obligations under performing of the activities on conformity assessment; 8. declaration that the person, the personnel and the subcontractors have not participated in the design, manufacture, delivery and installation of devices, which shall be assessed, and that they are not authorised representatives or consultants of the manufacturer; 9. copy of the documented conformity assessment procedures, subject of application; 10. declaration of impartiality in order to ensure that fulfillment of the personnel s obligations shall not be subject of moral pressure and financial incentives coming from persons, partial with the results from the assessment; 11. declaration that the personnel is bound by the requirement for protection of the professional secrecy regarding the information obtained during performing of the activities; 12. data for the professional experience of the personnel and of the subcontractors, if any, that proves the medical and technical competence, and the experience gained with the assessment of the devices, specified in the application, under procedures applicable for them, including experience of drawing up protocols, reports and certificates; 13. information about the technical devices, required for performing the tests and examinations, which are part of the conformity assessment procedures, available in his own test laboratories and/or contracted test laboratories, and copies of the certificates for accreditation of the laboratories, if any; 14. list of the standards referred to in Article 13, Paragraph1, or the monographs of the official Pharmacopoeia in the Republic of Bulgaria referred to in Article 13, Paragraph2, or the general technical specifications referred to in Article 13, Paragraph3, related to devices, specified in the application; 15. methods and instructions for test of devices for which the standards referred to in Article 13, Paragraph1, or of the official Pharmacopoeia monographs in the Republic of Bulgaria referred to in Article 13, Paragraph2, or the general technical specifications referred to in Article 13, Paragraph3, are not used; 16. copies of the documents, certifying completed education, training for auditor, professional and audit background according to the requirements of BDS EN ISO 19011, of the auditor who will perform the assessment of the quality system used, if required by the conformity assessment procedure; 17. manual and quality system procedures; 18. fee paid receipt for assessment of the submitted documentation according to the tariff referred to in Article 7, Paragraph1.

22 (4) In case that the person, applying for granting an authorisation for conformity assessment, submits accreditation certificate according to standards, laid down in the relevant ordinance referred to in Article 18, it shall be considered that a functioning quality system is available, and it meets the requirements for independence, impartiality, confidentiality and the necessary competence. In this case the person shall not submit the documents referred to in Paragraph3, points 8, 10, 11 and 17. Article 62. (1) The President of the State Agency for Metrology and Technical Surveillance shall appoint, by way of an order, an expert commission, which is to assess the documentation submitted under Article 61, Paragraph3 or 4. (2) The commission referred to in Paragraph1, shall consist of representatives of the State Agency for Metrology and Technical Surveillance, designated by its president, and of the BDA, designated by its Executive director. (3) If necessary, the commission referred to in Paragraph1, may involve external experts, who possess knowledge and practical experience in the field of the devices concerned. (4) In case of shortcomings and disparities with the requirements of the documentation referred to in Paragraph1, the President of the State Agency for Metrology and Technical Surveillance shall submit to the applicant a copy from the expert s assessment of the commission referred to in Paragraph1, and shall fix a two-month period of time for elimination thereof. Until the shortcomings and disparities are eliminated, the term referred to in Article 63, Paragraph5, shall be ceased. (5) In case that the applicant does not eliminate the shortcomings and disparities within the term referred to in Paragraph4, procedure shall be ceased. Article 63. (1) Within two months from the date of submission of the valid documentation referred to in Article 61, paragraphs 3 or 4, the commission referred to in Article 62, paragraph 1, shall perform on the spot check in order to ascertain the applicant s competence and his capabilities to perform the conformity assessment procedures stated. For performing of on the spot check a fee according to the tariff referred to in Article 7, paragraph 1, shall be paid. (2) In case unconformities between the submitted documentation referred to in Article 61, paragraph 3 or 4, and the requirements for conformity assessment, laid down in the ordinances referred to in Article 18, are found during the on the spot check, the President of the State Agency for Metrology and Technical Surveillance shall notify the applicant in writing, and shall fix two month term for elimination thereof. Until the disparities are eliminated, the time limit referred to in paragraph 5, shall be suspended. (3) In case that the applicant does not eliminate the unconformities within the term referred to in Paragraph2, the President of the State Agency for Metrology and Technical Surveillance shall refuse, by the way of a justified ordinance, the issue of the authorisation. (4) Commission referred to in Paragraph1, within two months from the on-site check, shall draw up an opinion to the president of the State Agency for Metrology and Technical Surveillance, giving the reasons for that proposal for approval of notification or for refusal. (5) Within six months from receipt of the documentation referred to in Article 61, paragraphs 3 or 4, the President of the State Agency for Metrology and Technical Surveillance shall notify the applicant that the last was approved for notification, or shall issue a justified ordinance for refusal.

23 Article 64. (1) The President of the State Agency for Metrology and Technical Surveillance, within three days from the notification referred to in Article 63, paragraph 5, shall communicate to the European Commission and the Member States the persons, approved under Article 61, paragraph 1. (2) The identification number of the persons referred to in paragraph 1, called "notified bodies", shall be determined by the European Commission. (3) The President of the State Agency for Metrology and Technical Surveillance shall issue to the notified bodies referred to in paragraph 2, an authorisation for performing conformity assessment. (4) The name and address of the body referred to in paragraph 2, the medical devices and the conformity assessment procedures shall be published in the Official Journal of the European Union. Article 65. The conformity assessment procedures may be performed by other bodies for conformity assessment, communicated to the European Commission by other Member States. Article 66. The authorisation for performing conformity assessment shall contain: 1. name of the body, issued the authorisation; 2. name, seat, business address and representative office of the notified body; 3. the medical devices and the conformity assessment procedures thereof; 4. date of issue of the authorisation; 5. the identification number of the notified body referred to in Article 64, paragraph2. Article 67. (1) In the register referred to in Article 19 of the Law on the Technical Requirements to Products shall be entered: 1. data referred to in Article 66; 2. date of withdrawal of the authorisation and the reasons for that. (2) Data referred to in paragraph 1, shall be published in the official bulletin of the State Agency for Metrology and Technical Surveillance. Article 68. (1) The notified bodies must notify the president of the State Agency for Metrology and Technical Surveillance in case of: 1. changes in the legal and accreditation status, the structure, scope of activities and the conformity assessment procedures; 2. changes in the quality system, the management or the personnel, that affect the implementation of the conformity assessment procedures; 3. change of the subcontractors; 4. changes in the circumstances, relating to the insurance referred to in Article 61, paragraph 3, point 7. (2) The persons referred to in paragraph 1 shall submit to the president of the State Agency for Metrology and Technical Surveillance the documentation, related to the changes, and shall pay a fee according to the tariff referred to in Article 7, paragraph 1. (3) Within one month from submission of the documentation referred to in paragraph 2, the expert commission referred to in Article 62, paragraph 1, and shall draw up an opinion

24 to the president of the State Agency for Metrology and Technical Surveillance for approval of the changes. (4) In case the changes referred to in paragraph 1, require on the spot check, the commission referred to in Article 62, paragraph 1, within two months from submission of the documentation under paragraph 2, shall draw up an opinion to the president of the State Agency for Metrology and Technical Surveillance for approval of the changes. (5) On the ground of the opinion referred to in Paragraphs 3 and 4, the President of the State Agency for Metrology and Technical Surveillance, by way of an order, shall issue supplement to the authorisation referred to in Article 64, Paragraph3. (6) In case that during the check of the documentation referred to in Paragraph2, or during the on-site check, shortcomings or disparities with the requirements of the ordinances referred to in Article 18 are found, the commission referred to in Article 62, Paragraph1, shall make out a prescription with a term for elimination thereof. Until the disparities are eliminated, the terms referred to in Paragraph3 or 4, shall be ceased. (7) In case that the notified bodies fail to fulfill the prescriptions referred to in Paragraph6, the President of the State Agency for Metrology and Technical Surveillance, by way of an order, shall refuse issue of the supplement to the authorisation. Article 69. In order to expand the scope of the authorisation for performing conformity assessment, an application in accordance with Article 61 shall be submitted. Article 70. (1) The notified bodies must submit to the State Agency for Metrology and Technical Surveillance an annual report for their activities, comprising of information about the conformity assessments of medical devices carried out, the claims presented, complaints and the steps for solving thereof, within 31 January of the next year. (2) Copy of the report referred to in Paragraph1, shall be submitted to the Executive director of the BDA. Article 71. (1) Commissions, appointed by way of an order of the President of the State Agency for Metrology and Technical Surveillance, shall inspect fulfilment of the conformity assessment procedures during the planned annual inspections. (2) Extraordinary on-site checks of the notified bodies shall be performed in receipt of warnings, complaints and claims, relating to their activities. (3) In case shortcomings in the activities of the notified bodies are found, the President of the State Agency for Metrology and Technical Surveillance shall issue a prescription with a term for elimination thereof. (4) The President of the State Agency for Metrology and Technical Surveillance shall issue an ordinance for suspending the activities of the notified bodies until elimination of the shortcomings referred to in Paragraph3. Copy of the ordinance shall be sent to the BDA. Article 72. (1) The President of the State Agency for Metrology and Technical Surveillance, by way of an order, shall withdraw the authorisation for performing conformity assessment, in case that during the inspections it is found that the notified body: 1. has stopped to meet some of the conditions, under which the authorisation was issued;

25 2. is not able to continue to perform the conformity assessment procedures; 3. does not perform the conformity assessment procedures according to the requirements of the relevant ordinances referred to in Article 18; 4. has not undertaken measures for elimination of the shortcomings referred to in Article 71, Paragraph3, within the specified term. (2) Copy of the ordinance referred to in Paragraph1, shall be sent to the BDA. Article 73. The President of the State Agency for Metrology and Technical Surveillance shall notify the European Commission and the Member States for the withdrawn authorisations referred to in Article 72, and for the performed changes referred to in Article 68, Paragraph1, point 1. Article 74. (1) The person, who received a refusal for issue of the authorisation referred to in Article 63, Paragraph5, may submit a new application for authorisation not earlier than 6 months from the date of serving the ordinance for refusal. (2) The notified body, whose authorisation has been withdrawn under Article 72, Paragraph1, may submit application for a new authorisation not earlier than one year from the date of serving the ordinance for withdrawal of the authorisation. Article 75. Refusal for issue of authorisation for performing conformity assessment, as well as the ordinance for withdrawal of authorisation, may be appealed in accordance with the Administrative Procedure Code. Article 76. (1) The notified body shall issue a certificate, certifying the conformity with the essential requirements, applicable for the device, with validity 5 years, or shall submit a justified refusal. (2) In case that the notified body finds that the manufacturer fails to meet the requirements, laid down in the ordinances referred to in Article 18, after risk assessment of the device s safety, the notified body may limit the scope of the certificate, suspend its validity or withdraw it. (3) The notified bodies must submit of the State Agency for Metrology and Technical Surveillance and to the BDA: 1. copy of all issued certificates, information for the refused certificates and for the certificates, which validity is suspended, or for withdrawn certificates at every three months; 2. additional information and the required documentation, related to the activities on conformity assessment - upon request. (4) The notified bodies must submit upon request the information referred to in Paragraph3, point 1, to the other notified bodies of the Member States. Chapter Five WHOLESALE TRADE IN MEDICAL DEVICES

26 Article 77. Wholesale trade in medical devices on the territory of the Republic of Bulgaria may be performed by natural or legal persons, which are registered as traders under the national legislation of a Member State or EEA State and hold authorisation for such activity, issued by a regulatory body of the state concerned. Article 78. (1) The persons referred to in Article 77, who wish to be granted an authorisation or certificate for wholesale trade in medical devices, shall submit to the BDA an application according to a model form, approved by the Executive director of the BDA, accompanied by the following: 1. certificate under Article 33 of Law on Commercial Register, or a relevant document under the national legislation of the Member State concerned or the EEA; 2. list of the medical devices, in both paper and electronic format; 3. fee paid receipt according to the tariff referred to in Article 7, Paragraph1. (2) If the persons referred to in Paragraph1, have storage facilities and facilities for wholesale trade in medical devices on the territory of the Republic of Bulgaria, they shall indicate in the application the address of these facilities. In this case, further to the documentation referred to in Paragraph1, the following shall be also attached: 1. act for putting into operation of the facilities, issued in accordance with the Law on Territory Structure; 2. document certifying the legal cause for use of the facilities; 3. declaration, drawn up by the persons referred to in Paragraph1, that: а) facilities meet the conditions for storage and wholesale trade in medical devices, specified in the list referred to in Paragraph1, point 2, according to their specifics and the instructions of the manufacturer, laid down in the instructions for use, and b) possess or use vehicles, providing the proper storage during distribution and transportation; 4. name, permanent address and mailing address of the person, appointed as a manager of the facilities for storage and wholesale trade in medical devices, as well as a copy of the contract, on the ground of which his legal relationship with the applicant has started. (3) The persons referred to in Article 77, who have issued certificate of registration or authorisation for wholesale trade in medical devices, issued by a regulatory body of another Member State or of EEA State, shall submit to the BDA: 1. copy of the authorisation or the certificate for wholesale trade, legally certified by a notary in the state concerned, accompanied by a legalized translation in Bulgarian language; 2. the documentation referred to in Paragraph1, points 2 and 3. (4) In case that the persons referred to in Paragraph3, have facilities for storage and wholesale trade in medical devices on the territory of the Republic of Bulgaria, they shall also submit to the BDA the documentation referred to in Paragraph2. (5) In case that the persons referred to in Paragraph3, do not have facilities for storage and wholesale trade in medical devices on the territory of the Republic of Bulgaria, they shall also submit to the BDA the name and the mailing address of his authorised representative. Article 79. (1) The Bulgarian Drug Agency shall consider the submitted documentation referred to in Article 78. (2) In case that shortcomings in the documentation referred to in Paragraph1, are found, the BDA shall notify in writing the applicant for elimination thereof. Until submission

27 of a valid documentation, the term under in Paragraph3 shall be ceased from the date of notification. (3) The Executive director of the BDA shall issue within 30 days from receiving of a valid documentation: 1. certificate for wholesale trade in medical devices to the persons referred to in Article 78, Paragraph3. 2. authorisation for wholesale trade in medical devices to the persons, other than those specified in point 1. Article 80. (1) Wholesale traders in medical devices shall submit to the BDA an application for change and/or supplement, for the change in: 1. the address of the facilities for storage and wholesale trade in medical devices in the cases referred to in Article 78, Paragraph2 and 4; 2. the person referred to in Article 78, Paragraph2, point 4 and/or his address; 3. the legal status, seat and/or business address of the trader; 4. the list of the types of medical devices he trades in; 5. the name and/or address of the authorised representative referred to in Article 78, Paragraph5. (2) Further to the application referred to in Paragraph1, all documents relating to the change, shall also be submitted. (3) The certificate or authorisation for change shall be issued by the Executive director of the BDA within 15 days from receiving the application referred to in Paragraph1. In case of change of the address of facilities for storage and wholesale trade in medical devices, the term shall be extended by 15 days. (4) The persons referred to in Paragraph1, must notify in writing the Executive director of the BDA, within 10 days after terminating their activities, related to the wholesale trade in medical devices. (5) In the cases referred to in Paragraph4, the Executive director of the BDA, by way of an order, shall cease the authorisation issued or shall nullify the certificate for wholesale trade issued. Article 81. The Bulgarian Drug Agency shall keep a register of the issued certificates or authorisations for wholesale trade in medical devices, containing: 1. number and date of the authorisations or certificates for wholesale trade in medical devices; 2. name, seat and business address of the persons referred to in Article 77; 3. date of cessation of the authorisations or certificates under point 1; 4. address of the facilities for storage and wholesale trade in medical devices; 5. name and address of the persons referred to in Article 78, Paragraph2, point 4; 6. name and address of the persons referred to in Article 78, Paragraph5. Article 82. (1) Wholesale traders in medical devices must only trade in medical devices, which expiry date has not passed and which have: 1. affixed CE marking in conformity with the requirements of Article 15; 2. affixed identification number of the notified body referred to in Article 64,

28 Paragraph2, if such body has participated in the conformity assessment; 3. affixed name and business address of the manufacturer and/or the authorised representative and the importer; 4. instruction for use, with the exception of devices for which this was not provided for in this Law. (2) The persons referred to in Paragraph1 must maintain the facilities referred to in Article 78, Paragraph2, in conformity with the requirements for storage of the corresponding type of device, specified by the manufacturer. (3) The persons referred to in Paragraph1, shall keep a record of: 1. purchased and sold quantities by type of medical devices, date of purchase and sale, the name and address of the wholesale traders or of the entities, referred to in Article 83, Paragraph1, points 2-4, with which they have traded in; 2. stock inventory of the medical devices, batch number and expiry date. (4) The persons referred to in Paragraph1, shall ensure and maintain documented system for tracing the safety of the medical devices, placed on the market, and for blocking and withdrawal from the market of the medical devices, which have demonstrated nonconformity with the safety requirements within the meaning of Chapter Seven. (5) Further to the documentation referred to in Paragraph3, the batch certificates of the medical devices shall be kept for 5 years, and shall be submitted upon request to the persons referred to in Article 86, Paragraph2. Article 83. (1) Wholesale traders may make business transactions with medical devices observing the requirements for their storage and distribution with: 1. other wholesale traders within the meaning of this Law; 2. medical establishments; 3. health facilities; 4. pharmacies and drugstores. (2) The Minister of Health shall designate, by way of an order, the medical devices which may be sold in entities, other than those listed in Paragraph1. Article 84. (1) The persons referred to in Article 86, paragraph 2, shall perform planned and unannounced inspections in the facilities for storage and wholesale trade in medical devices. (2) The persons referred to in paragraph 1, may require, check and make copies of the documentation referred to in Article 82, paragraphs 3 and 4, and take samples and specimens of devices under the conditions of Article 93, paragraph 3. (3) In case that the inspection proves the medical devices do not meet the requirements of Article 82, paragraph 1, points 1, 2 or 3, or the expiry date has passed, the Executive director of the BDA, by way of an order, shall suspend or withdraw the authorisation, or revoke the certificate for wholesale trade and shall order the blocking and withdrawal of devices, placed on the market and/or put into service. (4) In determining disparities of the facilities for storage and wholesale trade, with the requirements, specified by the manufacturer for the specific device, the persons referred to in paragraph 1, shall give prescriptions and term for elimination thereof. (5) In case that the inspection proves the documentation referred to in Article 82, paragraph 3, or the system referred to in Article 82, paragraph 4, have shortcomings or

29 discrepancies, the persons referred to in paragraph 1, shall give prescriptions and deadline for the elimination thereof. (6) In case that the disparities, shortcomings or discrepancies are not eliminated within the deadlines under paragraphs 4 and 5, the persons referred to in paragraph 1, shall submit opinion to the Executive director of the BDA with a proposal for withdrawal of the authorisation or for nullifying the certificate for wholesale trade. (7) An appeal may be lodged against the ordinances of the Executive director of the BDA referred to in paragraphs 3 or 6, in accordance with Administrative Procedure Code, and the appeal does non have suspension effect on them. Article 85. The Bulgarian Drug Agency shall notify the regulatory bodies of the Member States for the issued, suspended and withdrawn authorisations or certificates for wholesale trade in medical devices, and the reasons for that. Chapter Six SURVEILLANCE OF THE MARKET Article 86. (1) Surveillance of the market shall be performed in order to ensure the conformity of the medical devices, placed on the market and/or put into service, to the requirements of this Law and of the ordinances referred to in Article 18. (2) Surveillance of the market on the territory of the Republic of Bulgaria shall be carried out by the BDA, through inspectors and experts, appointed by way of an order of the Executive director. Article 87. (1) Surveillance of the market shall be performed by: 1. inspections of devices, placed on the market and/or put into service; 2. taking of specimens or samples from devices and the test thereof. (2) The test of the medical devices may not be performed by the notified bodies, participated in the conformity assessment of the same devices. Article 88. Inspections of the medical devices, placed on the market and/or put into service, shall be performed by: 1. previously approved annual surveillance plan of the market by groups of medical devices, by the Executive director of the BDA, and 2. warnings from other inspections bodies and in case of identified written warnings from citizens. Article 89. The persons, referred to in Article 86, paragraph 2, shall perform inspections in the entities referred to in Article 83, paragraph 1, points 2-4 and paragraph 2, as well as in the manufacturing facilities for medical devices. Article 90. The persons referred to in Article 86, paragraph 2, shall inspect:

30 1. the presence of CE marking and its conformity to the requirements of this Law; 2. the identification number of the notified body referred to in Article 64, paragraph 2, if such a body has participated in the conformity assessment of the medical device; 3. the presence of instruction for use and conformity of its content to the requirements of the ordinances referred to in Article 18, with the exception of the devices referred to in Article 2, paragraph 1, point 3, falling into class I and class IIа, in case these may be used safely without instruction for use; 4. the presence of batch number or serial number, if the relevant ordinance referred to in Article 18, require such number; 5. presence on the medical device of the name and business address of the manufacturer or the authorised representative and the importer; 6. expiry date of the medical device; 7. date on which the device, subject of registration under Chapter Two, has been placed on the market and/or put into service on the territory of the Republic of Bulgaria. Article 91. (1) In case the persons referred to in Article 86, paragraph 2, during the inspection find that the medical devices were placed on the market and/or put into service without CE marking or the expiry date has passed, they shall draw up opinion to the Executive director of the BDA, with a proposal for issuing of an order for blocking and withdrawal of the device from the market. (2) In case the persons referred to in Article 86, paragraph 2, during the inspection find that the medical devices were placed on the market and/or put into service without instruction for use, or its content is not in conformity with the requirements of the ordinances, referred to in Article 18, they shall give a prescription of the manufacturer or to his authorised representative, with a term for elimination of the infringement found. (3) If the infringement referred to in paragraph 2, shall not be eliminated within the specified term, the persons referred to in Article 86, paragraph 2, shall draw up opinion to the Executive director of the BDA, with a proposal for issuing of an order for blocking and withdrawal of the device from the market. (4) If any of the requirements of Article 90, points 2 and 4, is not met or the affixed marking does not meet the requirements of Article 15, the persons referred to in Article 86, paragraph 2, shall require from the manufacturer or from his authorised representative, or from the importer, to submit to them within 10 days: 1. declaration of conformity; 2. the technical documentation referred to in Article 14, paragraph 1. Article 92. (1) The persons referred to in Article 86, paragraph 2, shall draw up opinion to the Executive director of the BDA, who shall issue ordinance for blocking and prohibition the distribution of the device, unless the declaration of conformity and the technical documentation are submitted within the term referred to in Article 91, paragraph 4, except for the cases when the term under Article 14, paragraph 3, has expired. (2) Within 30 days from the date of submission of the ordinance referred to in paragraph 1 to the manufacturer, his authorised representative or the importer must withdraw the devices from the market.

31 Article 93. (1) Where it is found during the inspection of the documentation, referred to in Article 91, paragraph 4, that the content of the declaration of conformity does not correspond to the content, specified in the ordinances under Article 18, or after the inspection of the technical suspicions arise that the device does not meet the essential requirements, the persons referred to in Article 86, paragraph 2, shall take specimens or samples from the device for test. (2) The test shall be conducted in accredited laboratory from the Executive Agency Bulgarian Accreditation Service or in a laboratory, accredited by a body of Member State or EEA State. (3) Conditions and procedure for taking specimens and samples from medical devices for test shall be determined by way of an order of the Minister of Health and the Minister of Economy and Energy. (4) In case of contesting the results from the laboratory tests conducted, the manufacturer or his authorised representative shall submit to the BDA, within 7 days from the date of receipt of results from the first test, a written request for performing a second test. (5) The second test referred to in paragraph 4, shall be conducted by experts, who have not participated in the first test. Article 94. (1) In the cases referred to in Article 93, the Executive director of the BDA shall issue ordinance for suspending the distribution or use of the particular device. (2) Copy of the ordinance referred to in paragraph 1, shall be submitted to the manufacturer or to his/her authorised representative, or to the importer. Article 95. In case that the persons referred to in Article 86, paragraph 2, find that the non-conformity to the essential requirements may be eliminated, they shall draw up opinion to the Executive director of the BDA and shall give a prescription with a term, coordinated with manufacturer or his authorised representative, for performing the necessary corrective steps or for full conformity assessment of the device with the essential requirements. Article 96. (1) In case that the persons referred to in Article 86, paragraph 2, find that the non-conformity to the essential requirements may not be eliminated, they shall draw up opinion to the Executive director of the BDA. (2) The Executive director of the BDA, on the ground of the opinion, referred to in Paragraph1, shall issue ordinance for blocking and prohibition the distribution or use of the device, and shall order its withdrawal from the market within 30 days from the date of submission of the ordinance to the manufacturer or to his authorised representative, and to the importer. (3) The Bulgarian Drug Agency shall notify the ordinance referred to in paragraph 2, to the regulatory body of the Member State, where the manufacturer or his/her authorised representative and the importer are established. Article 97. Appeals can be lodged against the orders referred to in Article 92, paragraph 1, Articles 94 and 96, paragraph 2 and Article 99, paragraph 1, in accordance with the Administrative Procedure Code, and appeal do not have suspension effect.

32 Article 98. (1) In case that after the test referred to in Article 93, it is found that the medical devices do not meet the essential requirements, all expenses on taking specimens or samples for test shall be on the account of the manufacturer, of the authorised representative or of the importer. (2) In case that after the test referred to in Article 93, it is found that the medical devices meet the essential requirements, all expenses on taking specimens or samples for test shall be on the account of the BDA. Article 99. (1) The Minister of Health, at the suggestion of the Executive director of the BDA, may prohibit, by way of an order, placing on the market and/or putting into service, may limit the scope of operation or impose further requirements for placing on the market and/or putting into service of particular device or group of devices, if that is of interest for the public health. (2) In the cases referred to in paragraph 1, the BDA shall notify the European Commission and the regulatory bodies of the Member States for the ordinance, the reasons for it and the measures undertaken. Article 100. (1) The persons referred to in Article 86, paragraph 2, shall make insurance, at the expense of the BDA s budget, against accident, which may occur at the time or due to implementation of their business duties. (2) During performing of inspections, the persons referred to in Article 86, paragraph 2, may request assistance from RIPCPH, from the bodies of the Ministry of Interior and from competent bodies of the local government. Article 101. The Bulgarian Drug Agency shall publish on its web site information about devices, for which an ordinance referred to in Article 91, paragraph 1, Article 92, paragraph 1, Articles 94 and 96, paragraph 2, has been issued. Article 102. The persons referred to in Article 86, paragraph 2 must: 1. not disseminate circumstances and facts, which have emerged during or in regard to implementation of their business duties; 2. use the documents and information obtained solely for the purposes of surveillance of the market; 3. show their identity cards in performing inspections. Chapter Seven SYSTEM FOR NOTIFICATION AND ASSESSMENT OF INCIDENTS Article 103. (1) The manufacturer must create and maintain a documented system for tracing the safety of the medical devices, manufactured by him, placed on the market and/or put into service on the territory of the Member States, the EEA States and of third countries, and must have mechanisms for applying the necessary corrective actions.

33 (2) The system referred to in Paragraph1, shall be applied to medical devices: 1. with affixed CE marking; 2. which do not have affixed CE marking, in case the incident or the potential incident with them, within the meaning of Article 106, paragraphs 1 and 2, impose implementation of corrective actions, applicable for the devices under point 1. (3) The system shall not be applied to devices, intended for clinical tests, and devices for performance assessment. (4) The system referred to in paragraph 1 shall involve examination of the safety of devices referred to in paragraph 2, placed on the market and/ or put into service by: 1. collecting, documenting and analysis of notifications for the events, referred to in Article 105, from medical specialists, from patients, from persons, who carry out installation, maintenance or calibration of devices, and from the BDA; 2. analysis of the results from additional tests of devices, made out by the manufacturer; 3. collecting and documenting, and analysis of data from the scientific literature. Article 104. Physicians, dental therapists and other medical specialists, and the persons, who carry out installation, maintenance or calibration of the medical devices, must forthwith notify the manufacturer or the BDA for the events under Article 105, in the entities referred to in Article 83, paragraph 1, points 2 and 3. Article 105. (1) The manufacturer shall notify the BDA for each malfunction or deterioration in the characteristics, and/or performance of a device, manufactured by him, as well as for incomplete or incorrect information in the labelling or in the instructions for use, which has led or might lead to a decease or a serious deterioration in the state of health of the patient, medical specialist or third parties on the territory of the Republic of Bulgaria. (2) The manufacturer shall also notify the BDA for any technical or medical reason connected with the characteristics or performance of the device, which for the reasons, referred to in paragraph 1, is leading to a systematic withdrawal from the market of devices of the same type. Article 106. (1) The manufacturer shall submit to the BDA an initial report according to a model form within 10 days from receiving information about the event referred to in Article 105, which has led to decease or a serious deterioration in the state of health, hereinafter referred to as incident. (2) The manufacturer shall submit to the BDA an initial report according to a model form within 30 days from receiving an information about event referred to in Article 105, which might have led to a decease or a serious deterioration in the state of health, prevented due to a favourable circumstance or medical intervention, hereinafter referred to as potential incident. (3) In case the incident or the potential incident relates to devices of class IIа, IIb or class III, or in vitro diagnostic medical devices of List A or List B, or self-testing devices and has occurred in third country, the manufacturer shall, within the term under paragraphs 1 or 2, submit to the BDA an initial report in case the notified body, referred to in Article 64, paragraph 2, has carried out conformity assessment of the device, with which the incident

34 occurred. (4) In case the incident or the potential incident relates to devices of class I or in vitro diagnostic medical devices, not listed in List A and List B and not for self-testing, and has occurred in third country, the manufacturer shall, within the term referred to in paragraphs 1 or 2, submit to the BDA an initial report in case the manufacturer or his/her authorised representative is registered in the BDA in accordance with Chapter Two. Article 107. In case the incident or the potential incident is due to combined use of two or more devices and/or of accessories, made by different manufacturers, each manufacturer shall submit to the BDA an individual report referred to in Article 106. Article 108. The manufacturer shall, right after receipt of information for incident or potential incident, notify his authorised representative referred to in Article 10, paragraph 2, the whole sale trader and the notified body, carried out conformity assessment of the device with the essential requirements. Article 109. (1) The Bulgarian Drug Agency shall maintain a system for registration, analysis and summarizing of incidents and potential incidents with medical devices. (2) The Bulgarian Drug Agency shall publish on its Internet web site the manuals for tracing safety of the medical devices, issued from the European Commission and from the European Medicines Agency. Article 110. (1) The Bulgarian Drug Agency shall register in the system referred to in Article 109, paragraph 1, the data from the initial report of the manufacturer and shall assess the information submitted. (2) The Bulgarian Drug Agency shall implement surveillance on the actions of the manufacturer related to test of the incident or potential incident, and may issue prescriptions and directions. (3) During test of the incident or potential incident, the BDA shall, where necessary, assist the manufacturer for communications with: 1. the notified body, carried out the conformity assessment; 2. regulatory bodies of other Member States or EEA States concerned; 3. regulatory bodies of Member States or EEA States, for medicinal products in case of incidents or potential incidents with devices, referred to in Article 3, points 2, 3 and 4; 4. other manufacturers in the cases referred to in Article 107; 5. users of the device or with third parties. Article 111. In case the initial report referred to in Article 106, contains corrective actions or a conclusion that the incident compromises the safety of the patient, of the medical specialist or of third parties, however the corrective actions are not determined yet, the BDA shall send a report to the regulatory bodies of the Member States, the EEA States and to the European Commission. Article 112. (1) Within three months after sending the report referred to in Article

35 106, the manufacturer shall draw up and submit to the BDA final report according to a model form, approved by the Executive director. (2) The report referred to in Paragraph1 may include one of the following conclusions: 1. no measures must be undertaken; 2. additional tracing of the device or the batch of devices, put into service in the entities, referred to in Article 83, paragraph 1, points 2 and 3; 3. dissemination of information to the medical specialists in the entities under point 2, and in the pharmacies and drugstores, in the way of a written recommendation, drawn up by the manufacturer; 4. corrective actions in manufacture of future products; 5. corrective actions of the device, put into service in the entities under point 2; 6. withdrawal of the device or the batch of devices, placed on the market and/or put into service. Article 113. (1) In the cases referred to in Article 112, paragraph 2, point 2, the BDA shall monitor the actions of the manufacturer on the territory of the Republic of Bulgaria. (2) In the cases referred to in Article 112, paragraph 2, point 3, the BDA shall assess the content of the written recommendation and shall discuss with the manufacturer the addressees of recommendation and the way of its dissemination. (3) In the cases referred to in Article 112, paragraph 2, point 5, the BDA may carry out on the spot check. (4) The Executive director of the BDA shall issue an order for blocking and withdrawal by the manufacturer, of the device or the batch of devices, with which the incident or the potential incident has occurred, where it is found that the manufacturer has not: 1. carried out corrective actions within the term, specified by him in the report referred to in Article 112; 2. withdrawn the device or the batch of devices from the market within the term, specified by him in the report referred to in Article 112. (5) Conditions and procedure for blocking, withdrawal and/or disposal of devices, which do not meet the requirements of this Law, shall be determined by way of an order of the Minister of Health. Article 114. (1) The Bulgarian Drug Agency shall publish on its web site the list of devices, included in the ordinance referred to in Article 113, paragraph 4. (2) In case devices referred to in paragraph 1, are placed for sale in the entities referred to in Article 83, paragraph 2, the BDA shall notify the public through the Bulgarian News Agency and the mass media. (3) The Executive director of the BDA shall draw up report for the incident occurred or the potential incident in the cases referred to in Article 112, and shall send copy of it to the European Commission and the regulatory bodies of the Member States. Article 115. (1) Each direct message to the BDA for incident or potential incident with medical device on the territory of the Republic of Bulgaria, delivered by an identified person in writing, shall be documented in the system referred to in Article 109.

36 (2) Within three days from receipt of the message for the incident or potential incident, referred to in paragraph 1, the BDA shall inform the manufacturer, in order to take the steps, provided for in Article and Article 112. Article 116. The Bulgarian Drug Agency may be coordinating regulatory body: 1. in the cases of incident or potential incident, occurred on the territory of more than one Member State or EEA State, and 2. in case the incident or the potential incident is registered for a first time on the territory of the Republic of Bulgaria, or 3. in case the body, carried out the conformity assessment of the device with the essential requirements, has been granted an authorisation in accordance with Chapter Four, in case the incident or the potential incident has occurred with devices of class IIа, IIb or class III, or in vitro diagnostic medical devices of List A or List B, or self-testing devices, or 4. in case the manufacturer or his authorised representative is registered in the BDA in accordance with Chapter Two, in case the incident or the potential incident has occurred with devices of class I or in vitro diagnostic medical devices, which are not of List A and List B and are not for self-testing. Article 117. Personal data of the message source shall be kept with the BDA, observing the requirements of Law on Protection of the Personal Data. Chapter Eight THE EUROPEAN DATABASE Article 118. The Bulgarian Drug Agency shall submit to the European database immediately after its receipt, the following information in standardised format: 1. data relating to registration of the manufacturers or their authorised representatives, and of devices under Chapter Two; 2. data obtained from clinical tests of medical devices in accordance with Chapter Three; 3. data obtained at tracing the safety of the medical devices, placed on the market and/or put into service on the territory of the Republic of Bulgaria in accordance with Chapter Seven; 4. data, relating to the issue, change, supplement, temporary cessation, withdrawal or refusal of certificates from the notified bodies, according to the procedures, specified in the ordinances referred to in Article 18. Chapter Nine ADMINISTRATIVE PENAL PROVISIONS

37 Article 119. Anyone who places on the market and/or put into service medical devices, without assessing conformity according to the requirements of this Law and of the implementing acts thereof, shall be fined BGN to Article 120. Anyone who draws up and/or use a declaration of conformity with content, which does not correspond to the content, laid down in the ordinances referred to in Article 18, provided the deed does not constitute an offence, shall be fined BGN 3000 to Article 121. Anyone who places on the market and/or put into service medical devices with CE marking in breach of the requirements of Article 15, shall be fined BGN 500 to Article 122. Anyone who places on the market and/or put into service medical devices with CE marking, without assessed conformity with the essential requirements, laid down in the ordinances referred to in Article 18, shall be fined BGN to Article 123. The persons, who submit medical devices to exhibitions, fairs, demonstrations, promotions, scientific and technical conferences in breach of Article 15, paragraph 11, shall be fined BGN 500 to Article 124. Anyone who places on the market and/or put into service medical devices in breach of the provision of Article 16, shall be fined from BGN 5000 to Article 125. Anyone who places on the market and/or put into service medical devices without instruction for use, with the exception of the devices referred to in Article 2, Paragraph1, point 3, falling within class I and class IIа, provided these might be used safely without instruction for use, shall be fined BGN 3000 to Article 126. Anyone who places on the market and/or put into service systems and/or sets or medical devices, intended by the manufacturer to be sterilized before use, in breach of the requirements of this Law and of the implementing acts thereof, shall be fined BGN to Article 127. Anyone who places on the market and/or put into service medical device, custom-made, in breach of the requirements of this Law, shall be fined BGN 5000 to Article 128. Anyone who performs wholesale trade in medical devices without affixed CE marking, shall be fined up to BGN Article 129. (1) Manager of medical establishment or healthcare facility, who allows using of medical devices without affixed CE marking, with the exception of custom-made devices, of devices, which are put into service before the entry into force of this Law, and of

38 devices referred to in Article 12, Paragraph1, shall be fined BGN 2000 to (2) The same penalty shall be imposed to a manager of medical establishment or healthcare facility, who allows use of devices without instruction for use or after the expiry date. Article 130. Anyone who carries out wholesale trade in medical devices after the expiry date, shall be fined up to BGN Article 131. Wholesale trader in medical devices, who breaches the requirements of Article 82, paragraph 2, shall be imposed pecuniary sanction amounting to BGN Article 132. Wholesale trader in medical devices, who breaches the requirements of Article 82, paragraphs 3, 4 or 5, shall be imposed pecuniary sanction amounting to BGN Article 133. Wholesale trader in medical devices, who breaches the requirements of Article 82, paragraph 1, points 2, 3 or 4, shall be imposed pecuniary sanction amounting to BGN Article 134. Anyone who performs wholesale trade in medical devices, without issued authorisation/certificate for wholesale trade in medical devices, shall be fined up to BGN Article 135. Wholesale trader, who does not observe the provision of Article 80, Paragraph1, shall be imposed pecuniary sanction amounting to BGN Article 136. Wholesale trader, who does not comply with the provision of Article 80, paragraph 4, shall be imposed pecuniary sanction amounting to BGN Article 137. Anyone who perform retail trade in medical devices without affixed CE marking or after the expiry date, shall be fined up to BGN Article 138. Anyone who perform retail trade in medical devices out of the entities referred to in Article 83, paragraph 1, point 4 and paragraph 2, shall be fined up to BGN Article 139. Anyone who places on the market and/or put into service medical devices on the territory of the Republic of Bulgaria, and has not registered them within the time lime as set out under this Law, shall be fined up to BGN Article 140. Anyone who does not comply with the provisions of Article 27, paragraph 3, Article 28, paragraph 5 and Article 29, paragraph 5, shall be fined up to BGN 3000.

39 Article 141. (1) Anyone who infringes the requirements for conducting clinical tests, in case the performed infringement does not constitute an offence, shall be fined BGN 5000 to , and in case of repeated performing of the same infringement BGN to (2) Medical specialist, who allowed and committed the infringements referred to in paragraph 1, may be punished also with deprivation of the right to exercise his/her profession for a period of 6 months to two years. (3) The penalty referred to in paragraph 2, shall be imposed by the Minister of Health on proposal from the Executive director of the BDA. Article 142. To the notified body, who does not comply with the requirement of Article 68, paragraph 1, a pecuniary sanction of BGN 2000 to 5000, shall be imposed. Article 143. To the notified body, who does not comply with the requirement of Article 70, paragraph 1, a pecuniary sanction amounting up to BGN 5000, shall be imposed. Article 144. Anyone who prevents the persons referred to in Article 86, paragraph 2, to perform their official duties in conformity with the provisions of Chapter Six, shall be fined BGN 6000 to Article 145. Manufacturer of medical devices, who breaks the provision of Article 103, paragraph 1, shall be imposed a pecuniary sanction from BGN 5000 to Article 146. Manufacturer of medical devices, who breaks the provision of Article 107, shall be imposed a pecuniary sanction from BGN to Article 147. Anyone who fails to notify an incident or potential incident with a medical device according to Article 104, shall be fined from BGN 1000 to Article 148. Anyone who fails to comply with the order referred to in Article 113, paragraph 4, of the Executive director of the BDA, shall be fined BGN to Article 149. Anyone who breaks the provisions of this Law or of the implementing acts thereof, in cases other than those referred to in Article , shall be fined BGN 1000 to 3000, and in case of repeated infringement BGN 3000 to Article 150. Anyone who fails to comply with an order, prescription or instructions of the BDA, shall be fined BGN 1000 to Article 151. (1) In case the infringements referred to in Article , are committed by legal persons or sole traders, pecuniary sanctions shall be imposed. The amount of the pecuniary sanction may not be less than the double amount of the stipulated minimum amounts of the corresponding fines, and may not be more than the double amount of the

40 stipulated minimum amounts of the corresponding fines. (2) The pecuniary sanction impose shall not preclude the imposing of a fine to the guilty officials. Article 152. (1) Infringements under this Law shall be ascertained by deeds, drafted by inspectors and experts, designated by order of the Executive director of the BDA. (2) The penal rulings shall be issued by the Executive director of the BDA. Article 153. The drafting of deeds, the issuing, appeal and execution of the penal rulings shall be carried out in accordance with the Law on Administrative Infringements and Penalties. Additional provisions 1. Within the meaning of this Law: 1. "Active implantable medical device" means any active medical device 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 the intervention. 2. "Active 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. 3. "Valid documentation" means any documentation, which content and completeness meet the requirements, provided for in a defined procedure under this Law. 4. "Importer" means any natural or legal person, established in the territory of a Member State or EEA State, and who imports medical devices from third countries on the market of the European Union. 5. "Assignor of clinical test means the manufacturer or his authorised representative, who is responsible for the commencement, management and/or financing of a clinical test. 6. "Chief researcher means the person, under whose management the researcher conducts the clinical test. 7. "Good Clinical Practice means a set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical tests. 8. "Member State means a state, member of the European Union. 9. "Identification data of the device means: а) data for the manufacturer, model and type number of the device, including software and accessories; b) intended purpose, defined by the manufacturer, including clinical indications and contraindications to the use and identification of the groups of patients, for whom it is intended; c) description of the device - description of the materials, which get in touch with human tissues or liquids, does the device include a medicinal product, human and/or animal tissues or derivatives thereof, or biologically active substances; d) instructions for installation and use of the device, including if special conditions

41 for storage and requirements for work are present - preparation before use - sterilization in case of reuse, safety check, measures to be taken after use; e) recommended training and experience needed for use of the device; f) description of the necessary medical and surgical procedures, accompanying the use of the device. 10. "Device for self-testing" means in vitro diagnostic medical device, intended by the manufacturer to be able to be used by lay persons in a home environment. 11. "Long-term invasive medical device means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body, and duration of its stay in the human body is more than 30 days. 12. "In vitro diagnostic medical device means any device which is a reagent, reagent product, calibrator, control material, kit (set), instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body, including blood and tissue, solely or mainly to providing information on: а) physiological or pathological state, or b) congenital abnormalities, or c) determining the safety and the compatibility with potential recipients, or d) monitoring of therapeutic measures. In vitro diagnostic medical devices are also the self-testing devices, receptacles for storage of specimens derived from the human body, with the exception of devices for general laboratory use, unless the device, as regards its characteristics, is specifically intended by the manufacturer for in vitro diagnostic examinations. 13. "In vitro diagnostic medical device for performance assessment means any in vitro diagnostic medical device, intended by the manufacturer for conducting of one or more examinations for performance assessment, conducted in laboratory for medical examinations or other appropriate environment out of the manufacturing site. 14. "Informed consent means any expression of will of an able person or of legal representative of a disable person, by which consent for participation in clinical test is expressed, after the person has been informed in full about the nature, significance, consequences and the risks of the test. The informed consent is in a written form and contains signature of the person and date. In case it is not possible for the person to express its consent in writing, the informed consent may be given orally in the presence of at least one witness. 15. "Calibrator and control material" means any substance, material or device intended by the manufacturer either to establish measurement of proportions or to verify the performance characteristics of in vitro diagnostic medical device in conjunction with the intended use of that device. 16. "Coordinating researcher means the person, who coordinates the researchers in conducting of multi-centre clinical test. 17. "Corrective actions" may include: withdrawal of the device, put into service; issue of a written recommendation, in which are described the measures to be taken; additional tracing or modification of the device put into service, with the purpose of improving the characteristics and its performance; change in the design, change of components of the device or change in the manufacturing process for the future manufacture of similar devices; change of the content of label or the instructions for use, etc. 18. "Critical analysis means: а) short description of the medical device - intended performance, type,

42 characteristics; b) analysis of the selected literature and all available data; c) critical analysis of the identified damages at the use of the device, the risks relating to them, and the relevant safety measures concerning patients, medical personnel and third parties; d) methods for selection of literature sources used, the statistical methods for analysis applied, the methods for assessment, type and duration of the test, heterogeneity of the population, involved in the test; e) final assessment of the benefits from the use of the device against the risk, taking into account the achievements of the current science and medical practice; f) conclusion to show whether the objectives of the assignment are achieved, identification of deficiencies in the conformity assessment of the device with essential requirements as regards the safety and intended clinical performance and, where appropriate - argumentation for conducting the clinical tests objectives and plan of the test. 19. "Person, established in the territory of a Member State or of EEA State means a legal subject, registered under the civil or trade legislation of a Member State or EEA State or established by the virtue of a normative act, and who has seat and business address in a Member State or in EEA State. 20. "Personal protective equipment means any device or appliance, intended to be used by an individual to protect him against one or more possible hazards, threatening his health and safety. The following shall also be considered as personal protective equipment: а) a set of devices or appliances, integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous hazards; b) a protective device or appliance combined, separately or inseparably, with personal non-protective equipment, used by the individual for performing of certain activity; c) interchangeable components of a personal protective equipment which are essential to its satisfactory functioning and used exclusively for this personal protective equipment. 21. "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, 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, and which is intended by the manufacturer to be used for human beings for the purpose of: а) diagnostics, prophylaxis, monitoring, treatment or alleviation of diseases; b) diagnostics, monitoring, treatment, alleviation of or compensation for an injury or handicap; c) test, replacement or modification of the anatomy or of a physiological process; d) control of conception. 22. "Medical device for clinical test means the medical device referred to in Article 2, Paragraph1, point 2 and 3, intended for conducting tests on people by a medical specialist in an adequate human clinical environment. 23. "Custom-made medical device means the medical device referred to in Article 2, Paragraph1, point 2 or 3, made in accordance with a written prescription of a duly qualified medical specialist or of a person with appropriate professional qualification, which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices, which are adapted to meet the specific requirements of the

43 medical specialist or any other user, are not considered to be custom-made devices. 24. "Multi-centre clinical test means a clinical test, which is conducted according to a single plan, but at more than one test centres/medical establishments and by more than one researcher. Test centres may be located on the territory of one Member State, of more than one Member States, or in Member States and in third countries. 25. "Monitor means an individual appointed by the assignor, who monitors whether the clinical test at each stage is conducted, recorded and reported in conformity with the plan, with the standard operational procedures, with the good clinical practice and with the applicable monitoring requirements. 26. "Person independent of the assignor means a natural person, who is acquainted with the characteristics and performance of the medical device, subject of the clinical test, and with the methodology for conducting of clinical test, and is financially independent of the assignor. 27. "Clinical test plan means a document stating the objectives, design, methodology, statistical methods and organization of the clinical test. 28. "Intended purpose means the use for which the medical device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials. 29. "Accessory means an article which whilst not being a medical device is intended specifically by its manufacturer to be used together with a medical device, to enable it to be used in accordance with the use intended by its manufacturer. 30. "Manufacturer means the natural or legal person who/which: а) is responsible for the design, manufacture, packaging and labelling of medical device before it is placed on the market under his own name or his trade mark, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; b) assembles, packages, processes, fully refurbishes and/or labels one or more readymade medical devices and/or assigns to them their intended purpose with a view to their being placed on the market for a first time under his own name. Natural or legal persons who assemble or adapt medical devices already placed on the market, to their intended purpose for an individual patient, shall not be considered manufacturers within the meaning of this Law. 31. "Putting into service means the stage at which a ready for use as intended medical device is supplied for the first time to the end user in a Member State or in EEA State. Putting into service of active implantable medical device is its supply to a qualified medical specialist for implanting. 32. "Placing on the market means the first making available for distribution and/or use on the territory of the European Union and on the EEA territory, in return for payment or free of charge, of a new or fully refurbished medical device other than a medical device for clinical test and of in vitro diagnostic medical device for performance assessment. 33. "Serious deterioration in the health means: 1. a life-threatening state or disease, or injury; 2. a permanent impairment of a body function or of human organ or tissue; 3. a state that calls for medical aid or surgical intervention to prevent the impairments referred to in point "Specimen receptacles of specimens derived from the human body" are in vitro diagnostic medical devices, whether vacuum-type or not, specifically intended by their

44 manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examinations. 35. "Essential change in the clinical test plan means any change in the plan and/or in the information of the accompanying documentation that affects: а) the safety or the physical and psychic inviolability of the participants; b) the scientific value of the test; c) the conducting or organization of the test. 36. "Retail trade" means all activities on acquisition, storage and sale of medical devices in pharmacies, drugstores or in the entities referred to in Article 83, Paragraph2, to the end user. 37. "Wholesale trade" means all activities on acquisition, storage, import or export of medical devices with the purpose of sale, with the exception of retail trade. 38. "Authorised representative means a natural or legal person, established in the territory of a Member State or EEA State, explicitly authorised by the manufacturer to operate on his behalf and on his account to the regulatory bodies on the territory of the Republic of Bulgaria when performing the manufacturer s obligations under this Law. 2. This Law implements the provisions of 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 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices. 3. (1) The names and the registration numbers of the harmonized European standards and of the monographs of the European pharmacopoeia for the medical devices shall be published in the Official Journal of the European Union. (2) The harmonized European standards shall be implemented identically by publishing the standard s text translated into Bulgarian language or by confirmation for implementation as a Bulgarian standard in accordance with the Law on National Standardization. (3) The names and the registration numbers of the Bulgarian standards, implementing the harmonized European standards, shall be published in the official bulletin of the State Agency for Metrology and Technical Surveillance, and reference to the relevant ordinance referred to in Article 18 must be published. 4. (1) The requirements for assessment and reassessment of the performance, placing on the market and/or putting into service of batches, reference methods and reference materials for in vitro diagnostic medical devices, shall be determined by the general technical specifications. (2) The general technical specifications shall be published in the Official Journal of the European Union. Transitional and final provisions 5. (1) Traders who were issued an authorisation for wholesale trade in drugs -

45 medical devices, issued after 29 December 2002 in accordance with the repealed Law on Drugs and Pharmacies in Human Medicine (published, SG No. 36 of 1995; No. 61 of Decision No. 10 of the Constitutional Court of 1996; amended, No. 38 of 1998, No. 30 of 1999, No. 10 of 2000, No. 37 of Decision No. 3 of the Constitutional Court of 2000; amended, No. 59 of 2000, No. 78 of Decision No. 7 of the Constitutional Court of 2000; amended, No. 41 of 2001, Nos. 107 and 120 of 2002; revised, No. 2 of 2003; amended, Nos. 56, 71 and 112 of 2003, Nos. 70 and 111 of 2004, Nos. 37, 76, 85, 87, 99 and 105 of 2005, Nos. 30, 31, 34, 75 and 105 of 2006; repealed SG No. 31 of 2007), shall, within three months from the entry into force of this Law, submit an application according to a model form for official entry in the register referred to in Article 81, accompanied by the documents referred to in Article 78, Paragraph1, points 1 and 2, Paragraph2, points 3 and 4, and a declaration that there is no change in the address of the facilities for storage and trade. (2) Within 30 days from receipt of the documentation referred to in Paragraph1, the Executive director of the BDA shall issue an authorisation for wholesale trade in medical devices. (3) Issue of the authorisation referred to in paragraph 2, shall terminate the authorisation for wholesale trade, issued in accordance with the repealed Law on Drugs and Pharmacies in Human Medicine. 6. Traders who were issued a permanent authorisation for wholesale trade in drugs, issued after 29 December 2002 in accordance with the repealed Law on Drugs and Pharmacies in Human Medicine, who trade in medical devices as well, shall submit an application and documentation for authorisation for wholesale trade in medical devices in accordance with this Law until 31 December Traders who were issued a permanent authorisation for wholesale trade in drugs, issued before 29 December 2002 in accordance with the repealed Law on Drugs and Pharmacies in Human Medicine, who trade in medical devices, shall submit an application and documentation for authorisation for wholesale trade in medical devices in accordance with this Law until 31 December Applications for issue of authorisations for wholesale trade in medical devices, applied until the entry into force of this Law, shall be considered and concluded under conditions and in accordance with the procedures, provided for in this Law. 9. (1) Authorisations for use of medical devices issued in accordance with the repealed Law on Drugs and Pharmacies in Human Medicine shall be terminated from the date of entry into force of this Law. (2) Manufacturers of medical devices under Article 29, Paragraph1 and 2, whose authorisation has been terminated in accordance with Paragraph1, shall submit a notification according to a model form, to the Executive director of the BDA within three months from the entry into force of this Law. 10. All quantities of medical devices, whose conformity has not been assessed to

46 the essential requirements in accordance with Directives 90/385/EEC, 93/42/EC and 98/79/EC, and which are available in warehouses for wholesale trade, pharmacies, drugstores, optics stores and other commercial entities, may be sold until finishing the quantities, but not later than one year from the entry into force of this Law. 11. Medical devices shall be made, preserved and renewed as state reserves and war-time stocks under the conditions and in accordance with the Law on State Reserve and War-Time Stocks and the implementing acts thereof. 12. The Council of Ministers shall perform changes in the rules of the BDA and of the State Agency for Metrology and Technical Surveillance, within three months from the day of publishing of this Law in "The State Gazette". 13. The implementing regulations of this Law shall be issued within six months from the day of its publishing in the State Gazette. 14. The following amendments shall be made in the Law on the Integration of People with Disabilities (published, SG No. 81 of 2004; amended, Nos. 28, 88, 94, 103 and 105 of 2005, Nos. 18, 30, 33, 37, 63, 95, 97 and 108 of 2006, No. 31 of 2007): 1. Article 8, point 1, shall be amended as follows: "1. shall register persons, who carry out activities on providing of supportive devices, appliances and facilities for people with disabilities, and medical devices, specified in the lists referred to in Article 35а, Paragraph1, and control adherence to the approved criteria for their supply;". 2. In Article 15, Paragraph2, point 8 shall be amended as follows: "8. prescription of medical devices, supportive devices and facilities." 3. Article 35 shall be amended as follows: "Article 35. (1) For providing of supportive devices, appliances and facilities, and medical devices referred to in Article 44, Paragraph3, the Agency for People with disabilities shall keep a register of the persons, carrying out these activities. (2) The activities on providing of supportive devices, appliances and facilities, and medical devices shall be performed by persons, registered as traders in accordance with the national legislation of the Member State or the EEA State. (3) For entry in the register referred to in Paragraph1, the persons shall submit an application to the Executive director of the Agency for People with Disabilities, accompanied by the necessary documents, laid down in the provision referred to in paragraph 5. (4) Within one month from the date of submission the application referred to in Paragraph3, the Executive director of the Agency for People with Disabilities shall issue certificates of the persons, entered in the register. (5) The Minister of Labour and Social Policy shall issue an ordinance on the requirements for implementing the activities on providing of supportive devices, appliances and facilities for people with disabilities, and medical devices, specified in the lists referred to in Article 35а, Paragraph1." 4. A new Article 35а shall be inserted: "Article 35а. (1) The Minister of Labour and Social Policy, in coordination with the

47 Minister of Health, shall, on an annual base, approve lists of: 1. the supportive devices, appliances and facilities for people with disabilities; 2. the medical devices, intended for people with disabilities. (2) In case of doubt whether a certain product is a medical device or supportive device, appliance or facility for people with disabilities, an interdepartmental expert commission, established by way of an order of the Minister of Labour and Social Policy and of the Minister of Health, shall produce the final opinion. (3) Conditions and procedure for the work of the commission referred to in paragraph 2, shall be defined in the Implementing Rules to this Law." 5. Article 44 paragraph 3 shall be amended as follows: "(3) Persons with disabilities, according to their necessities, may receive earmarked allowances and relief for purchase and repair of supportive devices, appliances, facilities and medical devices, specified in the lists referred to in Article 35а, paragraph 1, except for the medical devices, which are paid in full or in part by the National Health Insurance Fund." 6. In 1 of the additional provision, point 7 shall be amended as follows: "7. "Supportive devices, appliances and facilities" are facilities, intended by the manufacturer to compensate lost or injured function of a human organ, with the purpose of increase the capacities for self-service, for performing of labour and any other activity by people with disabilities." 15. In the Law on Health (published, SG No. 70 of 2004; amended, No. 46, 76, 85, 88, 94 and 103 of 2005, No. 18, 30, 34, 59, 71, 75, 81, 95 and 102 of 2006, No. 31 of 2007), in 1 of the additional provision in point 9 (h) the word "medicines" shall be replaced by "medicinal products and medical devices". 16. This Law shall enter into force on the day following its publication in the State Gazette, with the exception of the provision of Article 4, paragraph 2, which shall enter into force on 29 December This Law has been adopted by the ХХХХ National Assembly on 29 May 2007, and the official seal of the National Assembly has been affixed. Annex to Article 15, paragraph 1

48