Essentials of European Medical Device Regulatory Affairs

Vigilance /PMS/PMCF Relationship

QMS

PMS NBMed 2.12 Vigilance

MedDev 2.12-1 Reactive PMS Proactive PMS Post Market Clinical Follow-up MedDev 2.7.1 & 2.12-2

Today’s Objectives were... • To provide a basic understanding of European medical device regulatory requirements and how to ensure compliance

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