The new Medical Devices Amendment Regulations 2024, which update the UK Medical Devices Regulations 2002, affects all medical devices in Great Britain. The amendment increases post-market surveillance (PMS) requirements, creating challenges for manufacturers who must ensure comprehensive PMS processes, thorough documentation, and the safety and performance of their devices.
Key changes:
- Mandatory PMS plan requiring patient and public feedback.
- Expanded reporting obligations to the UK Responsible Person (UKRP) and authorized bodies (AB) for preventive and corrective measures.
- Stricter content and deadlines for Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR).
- New trend reporting rules for significant incident increases.
Uncertainty and sources for incompliance:
- Short deadlines for providing the MHRA with requested documents and information.
- Varying time definitions (days, calendar days, UK working days) creating uncertainty.
Manufacturers should be aware of the changes and start preparing all necessary adaptations to continue to comply with the new requirements.
