The European Commission’s Medical Device Coordination Group posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for postmarket clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators.
The new guidelines address the differences between MDD and MDR in technical, biological and clinical criteria for demonstrating equivalence;
explain how to generate sufficient clinical evidence to demonstrate conformity to the relevant general safety and performance requirements (GSPR) for legacy devices CE marked in accordance with the MDD and AIMDD as well as outlines recommendation for conducting clinical evaluations;
In two separate guidances, the MDCG provides templates for postmarket clinical follow-up plans and evaluation reports which consider specific MDR requirements for developing PMCF plans and evaluation reports.
In the guidance on ventilators and related accessories, the MDCG explains regulatory options to place devices on market during the coronavirus (COVID-19) pandemic and explains the regulatory implications for various approaches for manufacturers and companies supplying parts or finished devices to medical device manufacturers and companies looking to place new ventilators on the market.
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Link to the full guidance:
MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories