The application of the principle of equivalence to the clinical evaluation of medical devices is particularly challenging.

We know very well what a significant change of (medical) devices is in the scope of the MDR since the publication of MDCG 2020-3 Rev1.

The use of clinical data of a "similar" medical device based on the principle of equivalence is highly problematic.

The end of the transition period for so-called legacy devices (medical devices provisionally placed on the market on the basis of...