reg 47 General matters relating to approved bodies
(1) An approved body to which an application has been made by a manufacturer or the manufacturer’s UK responsible person to perform the functions of an approved body under a conformity assessment procedure set out in these Regulations 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 the manufacturer’s UK responsible person has supplied information or data to an approved 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 the manufacturer’s UK responsible person supplies to an approved body in the course of a conformity assessment procedure set out in these Regulations shall, ..., be in English .... (4) An approved body shall, as respects a medical device which it has assessed ..., inform all other approved bodies and the Secretary of State of— (a) all certificates suspended or withdrawn; and (b) on request, all certificates issued or refused, and shall also make available to them, on request, any or all additional relevant information.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 an approved body finds, as respects a medical device which it has assessed ..., that— (a) the applicable requirements of these Regulations 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 approved body is aware of circumstances in which the Secretary of State may need to take action pursuant to regulation 61, the approved body shall inform the Secretary of State thereof. (6) The Secretary of State may request that an approved body supply to him any information and documents that the Secretary of State may, having regard to the terms of a mutual recognition agreement , need to supply to a Party to a mutual recognition agreement , and the body shall supply to him any and all information or documents so requested. (8) An approved body shall provide conformity assessment bodies with all the information it is required to provide to those bodies under a mutual recognition agreement . (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .