Bye bye MDD – Welcome MDR

Since the first, publicly viewable proposal of the EU for the Medical Device Regulation in 2012, over the publication of the final version in the EU Official Journal in 2017 and the postponement in 2020, the medical device industry has been preparing for May 26, 2021. And although one or the other MDD certificate is still valid until May 2024, as of today the important requirements of the MDR already apply, for example for the complex of PMS, vigilance and PMCF.

However, many other points, such as the ubiquitous question of sufficient clinical data for a wide variety of products, remain an important concern. The experts of novineon CRO will of course continue to support you with words and deeds and wish you a good start into the new era!