reg 44ZD Scope of Part 4A
(1) Subject to paragraphs (2) and (3), the requirements of this Part apply in respect of relevant devices that are— (a) put into service by the manufacturer, or (b) placed on the market, in accordance with Parts 2, 3 or 4 on or after the date on which the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 come into force. (2) The following regulations in this Part apply in respect of custom-made devices— (a) regulation 44ZC (interpretation of Part 4A); (b) regulation 44ZE (post-market surveillance system); (c) regulation 44ZF (post-market surveillance plan) except paragraphs (3)(g) and (h); (d) regulation 44ZG (preventive and corrective actions); (e) regulation 44ZH (initial reporting of serious incidents); (f) regulation 44ZI (investigation and final reporting of serious incidents); (g) regulation 44ZJ (field safety corrective actions and field safety notices); (h) regulation 44ZO (reports received by the Secretary of State); (i) regulation 44ZP (analysis of information received under Part 4A); (j) regulation 44ZQ (retention of post-market surveillance documentation); (k) regulation 44ZR (requests for post-market surveillance documentation). (3) This Part does not apply to— (a) devices intended for clinical investigation or performance evaluation; (b) devices placed on the market or put into service in accordance with an authorisation issued by the Secretary of State under regulation 12(5), 26(3) or 39(2). (4) In this Part, the relevant devices to which this Part applies are referred to as “ devices ”. (5) In this regulation, “ custom-made device ” means a device within the meaning of that term as defined in regulation 5 or regulation 20.