Post-market surveillance for medical devices

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.

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)

MHRA vigilance reporting requirements

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.

Medical device vigilance reporting timelines

Statutory timelines for reporting serious medical device incidents to MHRA, effective 16 June 2025.

Effective date: 16 June 2025
Serious public health threat: 2 calendar days from when manufacturer becomes aware
Death or unanticipated serious deterioration in health: 10 calendar days from when manufacturer becomes aware
All other reportable serious incidents (including anticipated serious deterioration): 15 calendar days from when manufacturer becomes aware
Previous reporting deadline (replaced): 30 calendar days
Reporting portal: MHRA MORE (Medical Online Reporting Environment)
Who must report: UK Responsible Person, manufacturer, or authorised representative
Reportable serious incident definition: Death of a patient, user, or other person; serious deterioration in the state of health; or a serious public health threat
Trend reporting: Required when statistical patterns of incidents are identified
Field Safety Corrective Action (FSCA): Required when investigation identifies risk to devices already on the market (e.g. recall, modification, additional warnings)
Geographic scope: Great Britain (England, Scotland, Wales)

MHRA Vigilance Reporting Requirements

Medical device vigilance reporting process

Step-by-step process for reporting serious medical device incidents to MHRA through the MORE portal, including reporting timelines, investigation, and field safety corrective actions.

Identify reportable incident – Determine whether the event is a reportable serious incident. A serious incident is one that directly or indirectly led to, might have led to, or might lead to death of a patient, user, or other person; serious deterioration in the state of health of a patient, user, or other person; or a serious public health threat. Near-misses where systematic failure is identified are also reportable.
Classify reporting timeline – Serious public health threat: report within 2 calendar days. Death or unanticipated serious deterioration in health: report within 10 calendar days. All other serious incidents (including anticipated serious deterioration): report within 15 calendar days. Timelines run from when the manufacturer becomes aware of the incident.
Submit initial report via MORE portal – Log in to the MHRA MORE (Medical Online Reporting Environment) portal. Complete the Manufacturer Incident Report (MIR) form. Provide device identification, incident description, patient outcome, assessment of causality, and corrective actions taken or planned. If all information is not available, submit a preliminary report within the timeline and follow up.
Investigate and submit follow-up reports – Conduct root cause investigation. Submit follow-up reports to MHRA as new information becomes available. Close the investigation with a final report including root cause analysis and corrective and preventive actions (CAPA).
Implement Field Safety Corrective Action if required – If investigation identifies a need for corrective action affecting devices already on the market (recall, modification, or additional warnings), notify MHRA via the MORE portal. Issue a Field Safety Notice (FSN) to users and distributors. Submit FSCA report to MHRA and notify all affected customers.

Vigilance reporting requirements (MHRA)

Business Context Testing

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Guvnor

Post-market surveillance for medical devices

Setting up your PMS system

Field Safety Corrective Actions

Data retention

Compliance Assistant

🧪 Business Context Testing

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Setting up your PMS system

Field Safety Corrective Actions

Data retention

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Business Context Testing

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