Module 16 2022

9/2/2022

Legacy Device Scenario 1 – Cardiovascular Implant

Actions to Support Claims: PMCF

• MDD CE certification based in clinical investigation performed • Ongoing registry of device implantation • Robust PMS process, trend analysis • Integrated processes: PMS, Risk management, CER and IFU

• PMCF Actions:

• Continue registry • Further clinical studies • Strengthen “generic” PMCF – monitor SOTA, literature review

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Legacy Device Scenario 2 – Surgical Instrument

Actions to Support Claims: PMCF

• MDD CE certification based in equivalence • Additional literature multiple single patient case studies • PMS well performed and data robust • No PMCF activity • Not all claims made supported by robust evidence • WET

• PMCF Actions:

• Implement Survey • Strengthen “generic” PMCF – monitor SOTA, literature review

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