mdi Europa has set up a check­list that is based on a for­mal tem­plate issued by the Ger­man com­pe­tent author­i­ty. The tem­plate is used when review­ing the Tech­ni­cal Doc­u­men­ta­tion, more specif­i­cal­ly the clin­i­cal eval­u­a­tion, of a manufacturer.

We think that this doc­u­ment may be a good tool for achiev­ing com­pli­ance with the enhanced require­ments as it pro­vides insights on what aspects of a clin­i­cal eval­u­a­tion com­pe­tent author­i­ties will look at.

If you are inter­est­ed in fur­ther infor­ma­tion, down­loads etc. 

You are wel­come to have a look at our Sup­port­ive Infor­ma­tion Sec­tion
Or read and save doc­u­ments in our Down­load Sec­tion MDR / IVDR