reg 42 Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices
(1) An approved body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure— (a) take account of the results of any assessment or verification operations which have been carried out ... at an intermediate stage of manufacture of the device; (b) take account of any relevant information relating to the characteristics and performance of that device, ...; and (c) lay down, by common accord with the manufacturer or their UK responsible person , the time limits for completion of the assessment and verification operations referred to in Annexes III to VII. (2) Where an approved body takes a decision in accordance with Annex III, IV, or V, they shall specify the period of validity of the decision, which, initially, shall be a period of not more than 5 years. (3) Where an approved body and a manufacturer or their UK responsible person have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or their UK responsible person , extend the period of validity of the decision for further periods of up to 5 years, each such period commencing on the expiry of the previous period.