With the much-discussed enforcement of the EU Medical Devices Regulation 2017/745, one might easily forget that the EU In Vitro Diagnostic Regulation 2017/746, or briefly IVDR, also entered into force in May 2017.
Companies need to update their technical documentation and processes to meet the new requirements. Compared to the IVDD no requirements have been removed, however, a list of new requirements has been added.
IVD manufacturers need to make significant efforts to be fully prepared for the transition from IVDD to IVDR.
Download the whitepaper to read how to prepare for compliance and which actions you need to take.