The Medical Devices Regulations 2002

General matters relating to UK notified bodies U.K.

47.—(1) A UK notified body to which an application has been made by a manufacturer or his authorised representative to perform the functions of a notified body under a conformity assessment procedure set out in the Medical Devices Directives shall perform those functions, in accordance with the requirements of the procedure, if those functions are within the framework of tasks which the body is designated to carry out.

(2) Where a manufacturer or his authorised representative has supplied information or data to a UK notified body in the course of a conformity assessment procedure, that body may, where duly justified, require the manufacturer to provide any additional information or data which it considers necessary for the purposes of that procedure.

(3) The information, data and correspondence that a manufacturer or his authorised representative supplies to a notified body in the course of a conformity assessment procedure set out in the Medical Devices Directives shall, if the notified body is within the United Kingdom, be in English or some other Community language acceptable to the notified body concerned.

(4) A UK notified body shall, as respects a medical device which it has assessed other than an active implantable medical device, inform all other notified bodies and the Secretary of State of—

(a) all certificates suspended or withdrawn; and

(b) on request, all certificates issued or refused,

and shall also make available to them, on request, any or all additional relevant information.

(5) Where a UK notified body finds, as respects a medical device which it has assessed other than an active implantable medical device, that—

(a) the applicable requirements of the Medical Devices Directives have not been met or are no longer met; or

(b) a certificate issued by it should not have been issued,

it may (having regard in particular to the principle of proportionality and the ability of the manufacturer to take appropriate corrective measures) suspend or withdraw the certificate issued in respect of that device or place restrictions on it, and in such cases, or in cases where the notified body is aware of circumstances in which the Secretary of State may need to take action pursuant to regulation 61, the notified body shall inform the Secretary of State thereof.

(6) The Secretary of State may request that a UK notified body supply to him any information and documents that the Secretary of State may, having regard to the terms of the Mutual Recognition Agreements, need to supply to a Party to the Mutual Recognition Agreements, and the body shall supply to him any and all information or documents so requested.

(8) A UK notified body shall provide conformity assessment bodies with all the information it is required to provide to those bodies under the Mutual Recognition Agreements.

[F1 (9) Subject to paragraph (10), a UK notified body that is designated to carry out the tasks referred to in article 5 of Directive 2003/32 shall, when performing conformity evaluation of a relevant device manufactured utilising either animal tissue which is rendered non-viable or non-viable products derived from animal tissue, evaluate the matters mentioned in article 5.2 of Directive 2003/32, and in so doing shall—

(a) take account of any relevant certificate of suitability that has been issued by the European Directorate for the Quality of Medicines in respect of either any animal tissues which are rendered non-viable or non-viable products derived from animal tissue which are utilised or intended to be utilised in that device; or

(b) if no relevant certificate of suitability is available—

(i) seek the opinion of the Secretary of State and through the Secretary of State the opinion of other Member States on the UK notified body’s evaluation and conclusions on the risk analysis and risk management of the animal tissues or products derived from animal tissue utilised or intended to be utilised in that device, as established by the manufacturer or his authorised representative, and

(ii) where the UK notified body receives any comments from the Secretary of State and where applicable from other Member States that have commented within twelve weeks of those opinions being sought by the Secretary of State, give due consideration to any such comments,

and where the Secretary of State’s opinion is sought pursuant to sub-paragraph (b)(i), the UK notified body shall supply him with the information and documents he needs or reasonably requests in order to formulate his opinion.

(10) Paragraph (9) shall not apply to a relevant device which is not intended to come into contact with the human body or which is intended to come into contact with intact skin only.]

Textual Amendments

F1 Reg. 47(9)(10) added (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 14