New guidance documents regarding clinical evaluation and follow-up of medical devices

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The new European guidance documents are directed towards manufacturers and notified bodies, offering helpful advice regarding the new framework for clinical investigations, clinical evaluations and post-market clinical follow-up of medical devices.

Clinical evaluation – Equivalence (MCDG 2020-5)
Provides advice for showing product equivalence when including the data in the clinical evaluation. The document also compares the similarities and differences between MEDDEV 2.7/1 rev 4 and MDR.

Clinical evidence needed for medical devices previously CE marked (MDCG 2020-6)
Describes what is needed to demonstrate that a device already on the market (legacy device) fulfills article 61 in MDR, i.e., the legacy device already has sufficient clinical evidence and does not need to be tested in clinical trials.

Post-market clinical follow-up plan template (MDCG 2020-7) &
PMCF evaluation report template (MDCG 2020-8)
Guidance on what a manufacturer’s plan for post-market clinical follow-up (PMCF) and a PMCF report should contain.

Our dedicated medical device experts and medical writers can support you in planning clinical investigations, clinical evaluations and PMCFs, as well as writing CIRs, CERs, PMCF reports, etc.

Contact us to learn more about how we can help.