Enhanced post-market surveillance requirements for medical devices
Strengthened PMS obligations for medical device manufacturers on the GB market, in force from 16 June 2025.
- Effective date
- 16 June 2025
- Applies to
- All CE and UKCA marked medical devices on the GB market
- PMS plan requirement
- Manufacturers must have a documented PMS plan proportionate to device risk class
- Proactive data collection
- Must actively collect and analyse safety data from market use
- Trend reporting
- Must report trends to MHRA when patterns of incidents or near-misses are identified
- Summary reporting
- Periodic summary reports required
- Vigilance reporting timelines
- Shorter statutory timelines apply (2/10/15 calendar days depending on severity; see mhra_vigilance_reporting_timelines snippet)
- Field Safety Corrective Actions (FSCAs)
- Must be notified to MHRA and communicated to users and distributors via a Field Safety Notice
- Reporting portal
- MHRA Online Reporting Environment (MORE) for all submissions
- UK Responsible Person
- Non-UK manufacturers must appoint a UK Responsible Person who assumes regulatory responsibilities including PMS liaison with MHRA
- PMS data retention (general devices)
- Minimum 10 years after last device placed on market
- PMS data retention (implantable devices)
- Minimum 15 years after last device placed on market
- Enforcement
- MHRA can suspend or restrict devices where PMS is inadequate, including suspension notices (s.25 MMD Act 2021) and safety notices (s.26 MMD Act 2021)