HPRA – MDCG Endorsed Guidance on MDR Clinical Investigations and Evaluations

The Medical Device Coordination Working Group (MDCG) on Clinical Investigation and Evaluation has developed guidance to assist with some of the key clinical requirements outlined in the Medical Device Regulation (MDR). The documents are as follows:

  • PMCF Evaluation Report Template

  • Guidance on PMCF Plan Template

  • Guidance on Sufficient Clinical Evidence for Legacy Devices

  • Guidance on Clinical Evaluation – Equivalence

The documents were endorsed by the MDCG and have been published on the website of the European Commission.The documents provide clarification on the expectations for ensuring generation of sufficient clinical data and how to demonstrate equivalence.

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