Periodic Safety Update Reports (PSURs)
PSURs are required for Class IIa, IIb, III, AIMD, and higher-risk IVD devices as part of ongoing conformity assessment obligations under Schedule 3 of the UK MDR 2002. PSURs must be made available to UKABs and to MHRA on request.
What is a PSUR?
A Periodic Safety Update Report (PSUR) is a formal document that summarises the conclusions of a manufacturer's post-market surveillance activities and confirms that the device's benefit-risk ratio remains acceptable.
The PSUR integrates:
- PMS data and analysis
- Clinical evaluation update conclusions
- Risk management update conclusions
- Vigilance reporting summary
- Complaint and adverse event data
- PMCF / PMPF data (where available)
PSUR frequency requirements
| Device class | Minimum PSUR frequency |
|---|---|
| Class IIa | At least every 2 years |
| Class IIb | At least annually |
| Class III | At least annually |
| AIMD | At least annually |
| IVD List B | At least every 2 years |
| IVD List A | At least annually |
| IVD Self-test | At least every 2 years (if UKAB involved) |
These are minimum frequencies — PSURs may be required more frequently if a safety signal warrants it.
Required contents of a PSUR
A well-structured PSUR covers:
1. Device identification
- Device name, model(s), classification, MHRA registration reference
- Period covered by the PSUR
- Date of previous PSUR (if applicable)
2. PMS data summary
- Volume of devices on the market during the period
- Number and type of complaints received
- Number and type of adverse events and serious incidents
- Number and type of FSCAs initiated
- Trend analysis outcomes
3. Clinical evaluation / performance evaluation update
- Summary of CER/PER conclusions
- New clinical evidence identified during the period
- Impact on benefit-risk assessment
4. Risk management update
- Any new hazards identified
- Changes to risk estimates for existing hazards
- New or revised risk control measures implemented
5. Benefit-risk determination
- Overall conclusion: does the benefit-risk ratio remain acceptable?
- Rationale for the conclusion
6. Corrective and preventive actions (CAPAs)
- CAPAs implemented during the period as a result of PMS findings
- Outstanding CAPAs with expected completion dates
7. Conclusions and next steps
- Overall safety and performance conclusion
- Next scheduled PSUR date
UKAB access and MHRA request
PSURs must be:
- Available to the UKAB — the UKAB may request PSURs as part of surveillance audits; this is standard practice
- Available to MHRA — MHRA can request PSURs as part of market surveillance or investigation activities
- Retained — for at least the period of the device's market life plus the applicable retention period
PSURs are not routinely published but are treated as confidential technical documents. MHRA may publish summary information in the event of a safety investigation.
Related pages
- PMS requirements by class
- Post-market clinical follow-up (PMCF)
- UK Approved Bodies — surveillance audits
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 3 | Ongoing surveillance obligations including PSURs |
| MHRA: Post-market surveillance guidance | PSUR requirements |
| EU MDR 2017/745, Art. 86 | EU PSUR requirements (applies in NI — detailed reference) |
If the PSUR concludes that the benefit-risk ratio is no longer clearly favourable, or if continued suitability for the market is in doubt, the manufacturer must take the following action immediately:
- Notify MHRA and the UKAB in writing within 10 working days, detailing the safety concern and proposed action
- Conduct a formal risk assessment to determine whether the device can remain on the market with additional controls
- Consider modifications to the device design, risk management, technical file, or IFU that would restore an acceptable benefit-risk balance
- If modifications are insufficient, evaluate whether the device should be withdrawn from the GB market
- Implement any agreed action (including FSCA, restricted distribution, restricted indication) without undue delay
- Document the decision, rationale, and actions in the vigilance file and next PSUR
- Cooperate with any MHRA investigation or enforcement action
Failure to take prompt action when a PSUR signals an unacceptable benefit-risk ratio may expose the manufacturer to enforcement action and personal liability.