Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software to support the implementation of the MDR and IVDR

Posted on 02.04.2020

The Medical Device Coordination Group (MDCG) endorsed the Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software, which was made available online on 17 March 2020. This document provides important guidance to manufacturers trying to collect clinical evidence for their medical device software (MDSW), i.e., software that involves a claim of a specific medical intended purpose and clinical benefit, which requires clinical evidence within its conformity assessment. Software that is intended to drive or influence a medical device is outside the scope of this guidance. The text also provides valuable indications on the level of clinical evidence that notified bodies will expect from MDSW manufacturers. Finally, practical examples of evaluation strategies for specific MDSW are included in an annex.