Essentials of European Medical Device Regulatory Affairs

Post Market Clinical Follow-up PMCF

PMCF Plan objectives: • Confirm safety and performance • Identify and monitor side effects • Identify and analysis emergent risks • Benefit –risk ratio • Identify misuse/off label use PMCF Plan content: • General methods e.g. user feedback, literature review • Specific methods e.g. PMCF study, registry • Rational for the methods • Reference to the CER and risk management

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Vigilance

What is Vigilance ? In the context of Medical Devices :- – Vigilance is… “system for the notification and evaluation of INCIDENTs and FIELD SAFETY CORRECTIVE ACTIONS (FSCA)

involving MEDICAL DEVICEs” (ref. MEDDEV 2.12-1, rev. 8)

MDR contains details previously only detailed in MEDDEV 2.12-1 rev 8

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