Module 16 2024

21/10/2024

What do I want my PMCF Strategy to achieve…?

• 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…?

• 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

• High-Quality Device user survey (healthcare professional)

• Device user survey (patient)

• Low-Quality Device user survey (healthcare professional)

• 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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