December 30, 2019. Read the latest CEO post on MDR; clinical evidence state of affairs at year’s end |


With less than 5 months to go until application, the development of guidance on the clinical evidence collection process under the EU MDR is progressing scarily slow.

The updated overview from December suggests we theoretically will get some more clinical guidance the next few days, but I would not bet on it. The 2-year delay in EUDAMED implementation, indeed, seems a valid argument to prioritize some clinical evidence guidances over others serving as input for EUDAMED. However, being in the process of preparing clinical evaluations, as well as pre- and postmarket clinical investigation documents, it would be very helpful to have some of the planned guidances available now, and not 2 minutes to midnight.