reg 41 Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices
(1) A manufacturer of a relevant device or, where applicable, their UK responsible person who is required to follow, or follows or has followed a conformity assessment procedure set out in this Part shall observe the manufacturer’s obligations set out in that procedure that apply to the manufacturer or, as the case may be, their UK responsible person . (2) A manufacturer of a relevant device or, where applicable, their UK responsible person shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with this Part at an intermediate stage of manufacture of the device. (3) A manufacturer or, where applicable, their UK responsible person shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Secretary of State— (a) the declaration of conformity for that device; (b) the technical documentation referred to in Annexes III to VIII relating to that device; and (c) the decisions, reports and certificates of approved bodies relating to that device, for a period ending five years after the manufacture of the last product. (4) A person who in the course of manufacturing relevant devices or devices for performance evaluation removes, collects, or uses tissues, cells or substances of human origin shall, in the course of removing, collecting or using those tissues, cells or substances act in accordance with the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine . (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .