Module 18 2021

06/02/2021

CDx requirements under IVDR – Challenges for clinical

• MedTech Europe has and continues to develop(ed) guidance documents. E.g. eBooklet CDx section helpful, but many questions remain unanswered. See MedTech eBook ref at end • ISO 20916: 2019 IVD medical devices — Clinical performance studies using specimens from human subjects — Good study practice is available but not EN standard and not harmonized by European Commission to IVDR • Guidance docs from the Medical Device Co-ordination Group (MDCG) due 2021:  IVDR Performance evaluation – extremely specialist, expertise needed  IVDR SSP (Summary of Safety & Performance)  IVDR Qualification of assays used in clinical trials of medicinal products1

3. Not all guidance on ‘how to’ meet requirements is available

The Organisation for Professionals in Regulatory Affairs

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Potentially.. A train crash waiting to happen.. (we will have to see what happens over the next few months)

The Organisation for Professionals in Regulatory Affairs

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