Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
What this means for your business
3
guides
- Enforced by
- MHRA
- Applies to
- United Kingdom
- On this page
- 3 practical guides
Practical guidance
Our guides explain how to comply with the requirements above.
Medical device compliance checklist
Verification checklist for medical device manufacturers and UK Responsible Persons. Covers device classification, conformity assessment, technical documentation, UKCA/CE marking, MHRA …
Post-market surveillance for medical devices
How to establish and maintain a post-market surveillance system for medical devices on the GB market under the enhanced requirements …
Report a medical device safety incident to MHRA
Step-by-step guide to reporting serious medical device incidents to MHRA via the MORE portal. Covers incident identification, timeline classification (2, …