Keeping track of MHRA device safety alerts is now more important than ever. With new post-market surveillance rules in place, the Medicines and Healthcare products Regulatory Agency (MHRA) is sharing more detailed updates on potential device risks. For clinicians, staying informed isn’t just about compliance – it’s a key part of delivering safe, high-quality care.
Where to Find the Latest Alerts
The MHRA publishes all Field Safety Notices (FSNs) and recalls on its Alerts, Recalls and Safety Information hub. Each notice explains which devices are affected, what the problem is, and what action needs to be taken.
You can also subscribe to the monthly Safety Roundup, which brings together the most recent alerts across medicines and devices. It’s an easy way to keep your team up to date without missing anything critical.
What’s Changed in 2025
This year has brought several big updates to medical device regulation in the UK:
1. New Post-Market Surveillance (PMS) Rules
From 16 June 2025, new regulations require manufacturers to monitor their devices more closely after they reach the market.
- All new products must meet stricter tracking and reporting standards.
- Manufacturers need to produce Post-Market Surveillance Reports and submit data through the MORE system by 16 October 2025.
- Expect clearer and more frequent alerts as a result.
2. Ongoing CE Mark Recognition
The UK will continue to recognise CE-marked devices indefinitely, helping ensure steady supply across the NHS and private sector.
3. Improved Traceability
The wider use of Unique Device Identifiers (UDI) makes it easier to trace affected equipment and carry out recalls quickly.
These changes mean alerts are becoming more structured and actionable – helping trusts respond faster when issues arise.
What to Do When an Alert Is Issued
When a new safety notice lands, follow a clear, step-by-step process:
- Check whether you’re affected
Compare model numbers, serials or lot codes against your local records or electronic systems. - Raise it with your governance lead
Let your Medical Devices Safety Officer (MDSO) or risk manager know straight away and log the alert in your reporting system. If needed, involve your Central Alerting System (CAS) contact to coordinate trust-wide action. - Take the recommended action
Follow the manufacturer’s instructions – that might mean quarantining stock, applying a software patch, or replacing a component. Keep a record of every step. - Report any incidents
If a patient was harmed or nearly harmed, submit a report through the Yellow Card Scheme. These reports help the MHRA identify national patterns. - Share and train
Brief your team in safety huddles or departmental meetings so everyone understands what’s changed. - Check completion
Revisit the alert after a few weeks to make sure all actions have been carried out.
What to Look For in Each Notice
When you review an FSN, focus on:
- Which devices or versions are affected
- What risk has been identified
- What actions are required and by when
- Any extra monitoring or retraining needed
- Whether accessories or consumables are included
Reading each alert carefully ensures the right response first time.
Staying Ahead
A proactive approach makes life much easier when an alert arrives:
- Subscribe to weekly FSNs and the monthly roundup
- Keep an up-to-date register of all devices, models and locations
- Set up a simple process for escalation and documentation
- Encourage reporting of faults or near misses
- Review and audit actions so nothing slips through the cracks
Building these habits shows strong governance and supports a culture of safety.
Why It Matters
Device alerts aren’t just administrative – they protect patients, reduce risk and build trust in your service. They also help:
- Clinical teams keep equipment safe and reliable
- Procurement leads assess supplier quality
- Governance teams meet MHRA expectations
- Trusts demonstrate compliance during inspections
Responding quickly and consistently is a mark of good clinical leadership.
Quick Reference Checklist
| Step | Action |
|---|---|
| Subscribe | Weekly FSNs and monthly Safety Roundup |
| Verify | Check affected models and serials |
| Escalate | Notify MDSO and CAS contact |
| Act | Follow manufacturer instructions |
| Report | Use Yellow Card for incidents |
| Review | Audit and close actions |
Summary
In 2025, MHRA device safety alerts are becoming clearer and more frequent under new surveillance rules. Clinicians should check the GOV.UK alerts hub regularly, act quickly on Field Safety Notices, and report any issues through Yellow Card. Keeping accurate registers, clear escalation routes and regular audits in place will help healthcare teams stay compliant, protect patients, and maintain high standards of safety.
