The MHRA has released a guidance document regarding the Post-Market Surveillance. To offer some background to this newly released guidance document, the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 updates the UK Medical Devices Regulations (MDR) 2002 by introducing a new section (Part 4A) that outlines post-market surveillance (PMS) obligations for medical devices, including in vitro diagnostic (IVD) and active implantable medical devices in Great Britain (GB). This includes notification requirements for incidents, as well as actions for device-related issues after approval for the GB market.
This document serves as guidance on interpreting the new regulations but is not exhaustive. For authoritative information, the full Statutory Instrument (SI) 2024 No. 1368 should be consulted.
Key changes are summarized in a table, highlighting how PMS requirements differ based on conformity assessment routes. The referenced table can be accessed using the following link.
Custom-made devices are subject to fewer PMS obligations, and specific rules apply to certain device types. Devices under clinical investigation, performance evaluation, or special authorisation in GB are not covered by these PMS requirements, nor are in-house manufactured devices by healthcare establishments.
Devices discontinued before June 16, 2025, the regulation’s effective date, are not subject to the new PMS requirements but must still comply with prior PMS obligations. However, devices placed on the market after this date must meet all new PMS requirements, and manufacturers may choose to implement a unified PMS system across all devices.
For devices in Northern Ireland, the regulations align with EU laws (EU MDR 2017/745 and EU IVDR 2017/746) and the guidance from the Medical Device Coordination Group (MDCG).
This newly released guidance document goes over several aspects including the following:
- Clarification of important terms
- Requirements of the manufacturers PMS system
- Reporting under the Medical Devices Vigilance System
The guidance document can be accessed using the following link
