Module 15 2022

19/05/2022

The PMCF plan

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

17

PMCF plan

• Annex XIV, Part B, (5, 6, 6.1) POST MARKET CLINICAL FOLLOW-UP • PMCF shall be performed pursuant to a documented method laid down in a PMCF plan • PMCF is a continuous process that updates the clinical evaluation • The manufacturer proactively collects and evaluates clinical data from the use of the device in or on humans • On the basis of factual evidence, the aim is to: • Confirm safety and performance throughout the expected lifetime of the device • Identify previously unknown side-effects and monitor known side effects and contraindications • Identify and analyse new/emergent risks • Ensure the continued acceptability of the benefit-risk ratio • Identify systematic misuse or off-label use with the view to verifying the intended purpose is correct

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 6

18

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