MDCG 2020-1 : Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software – March 2020

EN – This guidance provides a framework for the determination of the appropriate level of clinical evidence required for Medical Device Software (MDSW) to fulfil the requirements presented in the MDR and IVDR.

This document only applies to MDSW which are intended to be used, alone or in combination, with a medical purpose in accordance with the definition of a medical device in the MDR and IVDR.

There are three key elements to consider when compiling the clinical evidence for each MDSW :

• Determination of the validity of an MDSW output with a clinical condition or physiological state / scientific validity
• Technical Performance /Analytical Performance
• Clinical Performance.

Each of these elements is described in the guide according to the definition/determination/demonstration diagram.

Finally, the clinical evaluation/clinical performance evaluation process will be concluded with the final analysis and conclusions of the clinical evaluation (MD)/clinical performance evaluation (IVD) and a continuous update of this evaluation.