Module 16 2022

9/2/2022

What do I want my PMCF Strategy to achieve…?

PMCF Strategy

• Maintain all indications and claims for my legacy device • Meet the ongoing objectives of Annex XIV Part B • Use PMCF to inform future product development • Leverage PMCF as a market differentiator

• Tick the PMS/PMCF box CEAR Section F MDCG 2020-13

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What are my options…?

PMCF Options

• Non-clinical data generation (e.g. laboratory based claim, cadaver work)

• Usability / human factors (non patient) • Usability / human factors (patient) • New clinical investigation focused on specific population/indication • Extended follow-up of ongoing clinical investigation • Device user survey (healthcare professional) • Device user survey (patient) • Meta-analysis of literature (device and/or state of the art similar devices)

• Retrospective registry • Prospective registry

• Remove claims/lose CE certification

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