Read the latest CEO blog: MDR/ IVDR Clinical Evaluation toolkit part II |

I am very happy that as of April, we have more time until the date of application of the Medical Device Regulation, as well as more clinical guidance to work with. In my previous post I addressed my observations on the guidance for the clinical/ performance evaluation of Medical Device SoftWare, in this one I will focus on the one for equivalence (MDCG 2020-5).

https://medicaldevicesclinical.wordpress.com/