Essentials of European Medical Device Regulatory Affairs - June 2020

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

TheOrganisation for Professionals in 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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Post Market Clinical Follow-up PMCF

Annex XIV Part B

PMCF Plan content :

• Confirm safety and performance

• Identify and monitor side effects

• Identify and analysis emergent risks

Benefit –risk ratio

•

• Identify misuse/off label use

TheOrganisation for Professionals in Regulatory Affairs

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