Regulation 44ZQ Retention of post-market surveillance documentationF1
(1)
The manufacturer and the UK responsible person (if there is one) must retain the documentation drawn up for the purposes of this Part for the period set out in paragraph (2).
(2)
The period is the longer of—
(a)
the PMS period for the device model, and
(b)
15 years in the case of an implantable device, or 10 years in the case of any other device.
Annotations
Textual amendments
- F1
Pt. 4A inserted (E.W.S.) (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 4