Essentials of European Medical Device Regulatory Affairs - October 2019

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

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Post Market Surveillance PMS PSUR: Periodic safety update report

Electronic submission: • Manufacture submits PSUR • NB reviews + Evaluation + any actions • Available to Competent Authorities

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