Essentials of European Medical Device Regulatory Affairs - October 2019

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

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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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