Essentials of European Medical Device Regulatory Affairs

Post Market Surveillance PMS

PMS Report (article 85) • Required for Class I devices • Should contain: – Analysis of PMS data – Conclusions

– Rational and description of CAPAs

• Updated when necessary • Part of the technical documentation in Annex III • Available on request

The Organisationfor Professionals inRegulatory Affairs

Post Market Surveillance PMS

PSUR: Periodic safety update report (article 86) • Required for class IIa, IIb and III devices should contain: – Summary of results and analysis – Description of any CAPAs and rational – Conclusions of the benefit risk determination – Main findings of the PMCF •

– Volume of sales – Frequency of use – Characteristics of patient population

The Organisationfor Professionals inRegulatory Affairs