Essentials of European Medical Device Regulatory Affairs
Post Market Surveillance PMS PSUR: Periodic safety update report
Electronic submission: •
Manufacture submits PSUR
• NB reviews + Evaluation + any actions • Available to Competent Authorities
The Organisationfor Professionals inRegulatory Affairs
Post Market Clinical Follow-up PMCF
Annex XIV Part B a continuous process that updates the clinical evaluation Proactive collection and evaluation of clinical data
PMCF Plan Analyse findings PMCF Report Update clinical evaluation and risk management Implement CAPAs if needed
The Organisationfor Professionals inRegulatory Affairs
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