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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 reg 30

reg 30 Manufacturers etc. and conformity assessment procedures for active implantable 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 in the Annexes referred to in regulation 27(a) shall observe the manufacturer’s obligations set out in that procedure that apply to him. (2) A manufacturer of a relevant device or, where applicable, their UK responsible person shall, when following a conformity assessment procedure in the Annexes referred to in regulation 27(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. (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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