Module 16 2024

21/10/2024

Legacy Device Scenario 3 – Wound Dressing

• MDD CE certification based in equivalence • PMS highly reactive, large sales volumes but poor evidence of robust process • No PMCF activity • Not all claims made supported by robust evidence – limited data in some wound types • PMCF Actions: • Implement specific indication PMCF study(ies) (preferably in the EU) • Healthcare Professional survey? • Strengthen “generic” PMCF – monitor SOTA, literature review

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Legacy Device Scenario 4 – Washer Disinfector

• MDD CE certification Annex 1.1d (without clinical data) • PMS very limited, complaints only • No PMCF activity

• PMCF Actions: • Implement survey (via annual maintenance schedule)

• Implement usability assessment (via installation / user training) • Strengthen “generic” PMCF – monitor SOTA, literature review

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