Essentials of European Medical Device Regulatory Affairs - October 2019
Post Market Surveillance PMS
Post Market Surveillance Plan (Annex III): • Collection of information • Characterisation of the performance of the device • Comparison with similar products • Suitable indicators and thresholds for risk benefit analysis • Methods /tools/protocols: – to investigate complaints – Analysis of trends – Communication with CAs, NBs, EOs and users – Tracing devices • PMCF plan
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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
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