Name of law Law amending and supplementing the law on medical devices Named Bill a bill amending and supplementing the law on medical devices date of acceptance 14/05/2015 number/year Official Gazette 38/2015 Decree No 93

On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria

I DECLARE:

To be published in the Official Gazette the law amending and supplementing the law on medical devices, adopted by National HLIIÌ Rainier sat 14 may 2015.

Issued in Sofia on 20 may 2015.

The President of the Republic: Rosen Plevneliev

Stamped with the State seal.

Minister of Justice: Hristo Ivanov

LAW

amending and supplementing the law on medical devices (official SG. 46 2007; amend. 110/2008, no. 41 and 82 from 2009, no. 98 of 2010 No. 39 and 60 by 2011, issue 54 and 84 by 2012 and 14 by 2015.)

§ 1. In art. 1 is hereby amended as follows:

1. In paragraph 8. 1 item 3 shall be replaced by the following:

"3. the conditions and procedures for determining and monitoring of notified bodies.

2. paragraph 2 is replaced by the following:

"(2) the law aims to:

1. to ensure the placing on the market and/or putting into service of medical devices which do not endanger the life and health of patients, the medical profession or of third parties, when the products are used as intended and are stored, distribute, install, and maintain the implant in accordance with manufacturers ' instructions;

2. to ensure the implementation of Commission implementing Regulation (EC) No 920/2013 of 24 September 2013 for definition and monitoring of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Directive 93/42/EEC on medical devices (OB, L 253/8 of 25 September 2013), hereinafter referred to as the "Commission implementing Regulation (EC) No 920/2013". "

§ 2. In art. 6 make the following amendments and additions:

1. a new paragraph 2:

"2. the issued authorizations for the conformity assessment of medical devices in chapter IV;".

2. The former item 2, 3, 4, 5, 6, 7, 8 and 9 shall become paragraph 3, 4, 5, 6, 7, 8, 9 and 10.

3. Current item 10 going on 11, and after the words "in her art. 58, para. 1 "a comma and add" art. 67, para. 1. "

4. Current item 11 shall become item 12.

§ 3. In art. 7, para. 2, the words "and of the State Agency for metrological and technical surveillance in accordance with the activities carried out by them under paragraph 1. 1 ' shall be deleted.

§ 4. In art. 11, para. 4, the words "article. 64, para. 2 "are replaced by" article. 63, para. 4. "

§ 5. In art. 12, al. 1 the words "public health" shall be replaced by "public health and analyses".

§ 6. Article 61 shall be replaced by the following:

"Art. 61. (1) a permit for the conformity assessment of medical devices, including assessment of the clinical data is issued to a natural or legal person registered under the commercial law, the Executive Director of the BDA.

(2) the drug agency is designating authority within the meaning of art. 1, letter "e" of Commission implementing Regulation (EC) No 920/2013.

(3) the person applying for authorisation for the conformity assessment of medical devices, the FDA submitted to the electronic application form in accordance with annex II of Commission implementing Regulation (EC) No 920/2013, indicating the products and procedures for which they apply, the areas of competence and subdivisions of these areas – through the use of the information system of the European Commission's NANDO (notified and designated authorities of new approach) and the annexes to the application, referred to in annex II of Commission implementing Regulation (EC) No 920/2013.

(4) the applicant shall pay a fee for the issuance of a permit for the conformity assessment of medical devices in the amount set out in the tariff referred to in art. 7, para. 1. "

§ 7. Article 62 is amended as follows:

"Art. 62. (1) the assessment of the person asking for permission for the conformity assessment of medical devices is carried out by the Committee of experts, designated by order of the Executive Director of the BDA. If necessary, the Commission may be attracted to outside experts who possess the knowledge and practical experience in the field of medical devices.

(2) where the person applying for authorisation for the conformity assessment of medical devices, is indicated in the application under art. 61, para. 3 medical devices under art. 2, al. 1, item 1, the FDA assessment carried out by the procedure of art. 62. (3) where the person applying for authorisation for the conformity assessment of medical devices, is indicated in the application under art. 61, para. 3 medical devices under art. 2, al. 1, 2 or 3, the FDA assessment carried out by the procedure of art. 62 (a) of this law and of art. 3 of Commission implementing Regulation (EC) No 920/2013.

(4) drug agency applied the evaluation criteria of the person referred to in para. 2 or 3 in accordance with Annex I of Commission implementing Regulation (EC) No 920/2013. "

§ 8. Art is created. 62 (a):

"Art. 62. (1) the Expert Committee under art. 62, para. 1 and, where applicable, in parallel, a Committee of representatives of the governing bodies of the other two Member States and a representative of the European Commission, carried out a review of the submitted documentation.

(2) when establishing its incompleteness and inconsistencies with the requirements of the documentation, the Executive Director of the BDA shall notify the applicant and determined two months for their removal. To remove the inconsistencies and incompleteness deadline under art. 63, para. 1 or 2 stops flowing.

(3) where the applicant does not remedy the incompleteness and inconsistencies within the time limit referred to in paragraph 1. 2, the procedure shall be terminated.


(4) within 75 days of the date of the filing of valid documentation under art. 61, para. 3 the Commission shall, according to the Al. 1 carry out on-the-spot verification to establish the competence of the applicant and the opportunity to perform the requested conformity assessment procedures, including on-the-spot inspection of the subcontractor. To carry out on-the-spot inspection fee in the amount set out in the tariff referred to in art. 7, para. 1.

(5) where on-the-spot inspection identify inconsistencies between the documentation and the conformity assessment requirements laid down in the Ordinances under art. 18, the Executive Director shall notify the applicant and the FDA determined two months for their removal. To remove the inconsistencies, the time limit under art. 63, para. 1 or 2 stops flowing.

(6) where the applicant does not remedy the inconsistencies in definitions in para. 5 deadline, the Executive Director of the BDA with reasoned warrant, refuse to issue a permit.

(7) within 45 days of the on-the-spot check, the Commission shall draw up, prepare final committees respectively an assessment report, which is declared in the database of the NANDO information system. "

§ 9. Article 63 shall be amended as follows: "Article. 63. (1) in the cases under art. 62, para. 2 in the 4-month period from the filing of documentation under art. 61, para. 3 the Executive Director of the BDA on the basis of the report referred to in art. 62 (a), para. 7 shall notify the applicant that is approved for the notification, or issue a reasoned order.

(2) in the cases under art. 62, para. 3 within 6 months from submission of the documentation referred to in art. 61, para. 3 the Executive Director of the BDA on the basis of the report referred to in art. 62 (a), para. 7 shall notify the applicant that is approved for the notification, or issue a reasoned order.

(3) within three days of notification under paragraph 1. 1 or 2 BDA Announces approved persons by NANDO.

(4) the identification number of the approved and notified to the European Commission a conformity assessment body, hereinafter "notified body", is defined by the European Commission.

(5) the Executive Director of the BDA issue to the notified body referred to in paragraph 1. 4 permission for conformity assessment.

(6) the authorisation referred to in paragraph 1. 5 has a maximum validity of 5 years. Renewal of authorization is performed by the procedure of art. 62, para. 2 or 3. "

§ 10. Article 64 shall be amended as follows: "Article. 64. (1) where a person asking for permission for conformity assessment, presented the certificate of accreditation in accordance with the requirements laid down in the Ordinance under art. 18, it is assumed that it has a functioning quality system, meets the criteria of independence, impartiality and confidentiality and possess the necessary competence.

(2) in the cases referred to in para. 1 the person does not submit other documentation attesting to compliance with the criteria of para. 1. "

§ 11. Article 65 shall be replaced by the following: "art. 65. The conformity assessment procedures laid down in the Ordinances under art. 18, can be performed by notified bodies from other Member States. "

§ 12. In art. 66 is hereby amended as follows:

1. In the text before paragraph 1 the word "carrying" shall be deleted.

2. In paragraph 1, the words "the authority which granted the authorisation" shall be replaced by "designating authority".

3. In paragraph 5, the words "under art. 64, para. 2 ' shall be deleted.

§ 13. In art. 67 the following modifications are made:

1. In paragraph 8. 1 the text before point 1 shall be replaced by the following: "drug agency keeps a register that contains:".

2. in the Al. 2 the words "in the official bulletin of the State Agency for metrological and technical surveillance ' shall be replaced by" on the official website of BDA. "

§ 14. Art is created. 67:

"Art. 67. (1) the extension of the scope of the authorisation and the renewal of the authorisation for extension of the permission for conformity assessment shall be carried out by the procedure of art. 62, para. 2 or 3.

(2) the Executive Director of the BDA issue with an addition to the authorization under art. 63, para. 5. "

§ 15. In art. 68 following amendments and supplements shall be made:

1. In paragraph 8. 1:

and before that) the text shall be amended as follows: 1 "a notified body is required to notify the FDA at:";

b) point 1 shall be replaced by the following: "1. changes in the legal status and organizational structure;"

c) a new paragraph 2: "2. changes in the scope of its activities beyond the cases under art. 67 a, para. 1 changes in procedures for conformity assessment; "

d) existing paragraph 2 and 3 shall become paragraph 3 and 4;

(e)) the current item 4 becomes item 5 and in her words "under art. 61, para. 3, item 7 "shall be deleted.

2. in the Al. 2 the words "the Chairman of the State Agency for metrological and technical surveillance ' shall be replaced by" BDA ".

3. in the Al. 3 and 4, the words ' opinion to the Chairman of the State Agency for metrological and technical surveillance ' shall be replaced by "an evaluation report to the Executive Director of the BDA.

4. Paragraph 5 shall be amended as follows:

"(5) on the basis of the report referred to in paragraph 1. 3, respectively, and under para. 4 the Executive Director of the BDA issue with an addition to the authorization under art. 63, para. 5. "

5. in the Al. 7, the words "the Chairman of the State Agency for metrological and technical surveillance ' shall be replaced by" the Executive Director of the BDA.

6. a para. 8:

"(8) in the cases under art. 62, para. 2 evaluation of the documentation referred to in paragraph 1. 2 and on-the-spot verification referred to in paragraph 1. 4 shall be carried out, where applicable, and by the representatives of the other two Member States and by the representative of the European Commission, who participated in the assessment procedure under art. 62. "

§ 16. Article 69 shall be repealed.

§ 17. In art. 70 is hereby amended as follows:

1. In paragraph 8. 1 the words "State Agency for metrological and technical surveillance ' shall be replaced by" BDA "and the word" made "is deleted.

2. paragraph 2 is repealed.

§ 18. Article 71 shall be amended as follows:


"Art. 71. (1) the Commissions set by order of the Executive Director of the BDA, inspect the activities of notified bodies, including their subcontractors, by carrying out planned inspections by the procedure of art. 5, paragraph 1, letters "a" and "b" of Commission implementing Regulation (EC) No 920/2013.

(2) on receipt of the alerts, complaints and claims for failure to comply with the obligations of notified bodies or deviation from the normal or good practices the commissions under para. 1 carry out emergency checks on the spot.

(3) where checks reveal deficiencies in the activities of the notified bodies, the Executive Director of the BDA issue a prescription with a time limit for their removal.

(4) the Executive Director of BDA issued an order for the restriction or suspension of the authorisation to the removal of deficiencies within the period specified under paragraph 1. 3. "§ 19. In art. 72 is hereby amended as follows: 1. In para. 1 in the text before point 1, the words "the Chairman of the State Agency for metrological and technical surveillance ' shall be replaced by" the Executive Director of the BDA.

2. paragraph 2 is repealed.

§ 20. Article 73 shall be amended as follows:

"Art. 73. The Bulgarian drug agency shall notify the European Commission, other Member States, member countries of the agreement on the European economic area, Switzerland and the Swiss for withdrawal of authorisations under art. 72 and the changes made under art. 67 a, para. 1 and art. 68, para. 1. "

§ 21. In art. 74, para. 1 the figure "5" is replaced by "2".

§ 22. In art. 75 the word "carrying" shall be deleted.

§ 23. In art. 76 following amendments and supplements shall be made:

1. In paragraph 8. 1, after the word "validity" is a comma and add "specified therein, but not exceeding".

2. Paragraph 3 shall be amended as follows:

"(3) the notified body shall inform the FDA in the case of refusal to issue a certificate of validity of the certificate suspension, withdrawal or imposition of restrictions or modified or supplemented certificates."

3. a new paragraph. 4:

"(4) in the cases referred to in para. 3. the notified body shall provide, at the request of the FDA additional information and documents requested by the FDA. "

4. The current paragraph. 4 it al. 5 and in her words "the countries of the European economic area ' shall be replaced by ' the member parties to the agreement on the European economic area and Switzerland, the Swiss".

§ 24. Article 76 (a) shall be replaced by the following:

"Art. 76A. notified bodies shall provide the notified bodies designated by the other Member States, information about the canceled certificates certificates whose validity is temporarily suspended, and withdrawal of certificates, and, on request, for certificates issued. "

§ 25. In art. 82, para. 1, item 2, the words "article. 64, para. 2 "are replaced by" article. 63, para. 4. "

§ 26. In art. 90, para. 1, item 2, the words "article. 64, para. 2 "are replaced by" article. 63, para. 4. "

§ 27. In art. 106, para. 3 the words "art. 64, para. 2 "are replaced by" article. 63, para. 4. "

§ 28. In art. 143 and the words "art. 76 a, para. 1 "shall be replaced by" art. 76, para. 3 and 4 ".

§ 29. Article 152 shall be amended as follows:

"Art. 152. (1) the offences under this Act shall be established by regulations drawn up by inspectors and experts designated by order of the Executive Director of the BDA.

(2) the penal provisions shall be issued by the Executive Director of the BDA or by officials authorised by him. "

§ 30. In § 1 of the additional provisions establishes that 35A:

"35A." third country "means any State which is not a member of the European Union or is not a State party to the agreement on the European economic area, Switzerland or the Swiss."

§ 31. In the additional provisions § 4 is created:

"§ 4A. The Executive Director of the BDA may assign its powers under this Act to the Deputy Executive Director of BDA. "

Final provision

§ 32. The law shall enter into force on the day of its publication in the Official Gazette.

The law was passed by the National Assembly-43 on May 14, 2015 and is stamped with the official seal of the National Assembly.

President of the National Assembly Tsetska Tsacheva:

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