The MHRA, the UK Medicines and Healthcare products Regulatory Agency, released a new standardised format for the periodic safety update report (PSUR). Dated June 2025, the document guides manufacturers of medical devices and IVDs on what data to include within a PSUR. The guidance reflects the latest amendments to the UK Medical Devices Regulations to include the new provisions of the Post-market Surveillance Regulations applicable in Great Britain.
PUSR content for medical devices on the Great Britain market
The standardised format for periodic safety update report (PSUR) should be a stand-alone document. Overall, the report should include the following:
- Cover page with manufacturer details, medical devices covered, approved body information, PSUR reference number, version number, data collection period, table of contents
- Executive summary
- Description of the devices covered by the PSUR
- Device exposure information, such as volume of sales, size, and other characteristics of the population using the device
- Device performance information, including vigilance data, proactive data analysis from defined populations, data from other sources.
- Preventive and corrective actions (CAPA)
- Findings and conclusions
When a manufacturer decides that specific sections should not be part of their PSUR, they should document the justification in the report.
The new UK PMS Regulations already apply to medical devices and IVDs placed on the market in Great Britain. For any questions on compliance with UK requirements, contact us here or at mdlaw@obelis.net.
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