Theme Clinical evaluation – Software
Target Audience Manufacturers
Products concerned SaMD and Software as a part of a MD
Regulatory reference MDR (EU) 2017/745

Article 61

Article 2(51)


IVDR (EU) 2017/746

Article 56

Article 2(36)


Documents mentioned GHTF/SG5/N7:2012


MDCG 2019-11




ENThis 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.