Post-Market
Periodic Safety Update Report(PSUR)
In one line
Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
Definition
Per EU MDR Article 86, the PSUR summarizes results and conclusions of analyses of post-market surveillance data, including main findings of the PMCF, the rationale and description of preventive and corrective actions, and the volume of sales.
PSURs are required for Class IIa, IIb and III devices: Class IIb and III must update them at least annually, and Class IIa at least every two years. For Class III and implantable devices, the PSUR is submitted to the notified body through EUDAMED for evaluation, while for other classes it is kept available to the notified body and authorities. MDCG 2022-21 gives guidance on content and format.
Why it matters
PSUR frequency depends on device classification. Class IIb implantable and Class III devices require annual PSURs assessed by Notified Bodies.
Common pitfalls
- •Failing to integrate findings from all post-market surveillance activities, such as PMCF, into the PSUR is a common mistake.
- •Submitting a PSUR that lacks clear justification for chosen preventive and corrective actions can lead to regulatory non-compliance.
- •Incorrectly determining the submission frequency of the PSUR based on device classification or regulatory updates is a frequent error.
- •Omitting quantitative data, such as sales volumes, or qualitative insights that support the conclusions in the PSUR will lead to an incomplete report.
- •Not adequately linking the PSUR content to an updated risk-benefit assessment of the device can be a significant oversight.
Sources
- EU MDR Article 86 · EUR-Lex
- FDA MAUDE Database · FDA
- FDA Recalls - Medical Devices · FDA