Essentials of European Medical Device Regulatory Affairs - June 2020

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

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• Part of the technical documentation (content as Annex III) • Available on request

TheOrganisation for Professionals in Regulatory 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

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

TheOrganisation for Professionals in Regulatory Affairs

Post Market Surveillance PMS

PSUR: Periodic safety update report

Keep reports as part of the technical documents (audit/available on request) Electronic submission: • Manufacture submits PSUR • NB reviews + Evaluation + any actions • Available to Competent Authorities

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