October 11, 2019. MDCG issues Guidance on Qualification and Classification of Software in MDR |


“Manufacturers must ensure that all regulatory requirements for placing on the market and conformity
assessment have been fulfilled. As set out in Article 7 of MDR and IVDR, this also entails that any
claims, relating to the intended medical purpose of their MDSW are supported by clinical evidence. If
this is not the case, the software would not meet the requirements of the regulations and therefore may
not be CE marked as a medical device, nor present said claims.”