Report a medical device safety incident to MHRA
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Product compliance and marking
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 in force from 16 June 2025. Covers PMS plans, proactive data collection, trend analysis, summary reporting, Field Safety Corrective Actions, and data retention periods.
UK-wide
Guide summary
You must set up a system to monitor the safety of your medical devices after they are sold. This includes collecting data, reporting problems, and keeping records for 10-15 years. New rules started on 16 June 2025.
- Set up a post-market surveillance (PMS) system by 16 June 2025
- Create a PMS plan based on your device's risk level
- Actively collect safety data from users and other sources
- Report serious incidents within 2-15 days depending on severity
- Keep records for 10 years (15 for implantable devices)
- Tell MHRA about any safety actions like recalls
- Use the MHRA Online Reporting Environment (MORE) for submissions
- Appoint a UK Responsible Person if based outside the UK
- Monitor for patterns of problems and report trends
- MHRA can stop sales if your system is not good enough
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UK-wide
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If you place medical devices on the Great Britain market, you must operate a post-market surveillance (PMS) system proportionate to your device's risk class. Enhanced PMS requirements came into force on 16 June 2025 under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
These requirements apply to all CE and UKCA marked medical devices on the GB market, including devices already on the market before 16 June 2025.
Setting up your PMS system
Your PMS system must include:
- PMS plan: A documented plan describing how you will collect, analyse, and act on post-market data. The plan must be proportionate to your device class and type.
- Proactive data collection: You must actively seek safety and performance data, not just wait for complaints. Sources include customer feedback, published literature, registry data, and field service records.
- Trend analysis: Monitor for statistical patterns of incidents or near-misses. Report trends to MHRA when identified.
- Summary reporting: Prepare periodic summary reports on device performance and safety findings.
- Complaints handling: Investigate all complaints systematically. Determine whether each complaint constitutes a reportable serious incident.
Field Safety Corrective Actions
If your investigation identifies a risk to devices already on the market, you must take a Field Safety Corrective Action (FSCA). This may include:
- Recalling the device from users
- Modifying the device (hardware, software, or labelling update)
- Issuing additional warnings or instructions
You must notify MHRA of FSCAs via the MORE portal and issue a Field Safety Notice (FSN) to all affected users and distributors.
Data retention
PMS records must be retained for a minimum of 10 years after the last device is placed on the market. For implantable devices, the retention period is 15 years.