As of May 26, 2021, the 93/42/EEC Medical Device Directive (MDD), which was previously used as the basis for CE certification processes for Medical Device Manufacturers, was repealed by the European Commission, and replaced with the 2017/745/EEC Medical Device Regulation (MDR).

The new Regulation introduces several new requirements, including Clinical Investigations, Post-Market Clinical Follow-up, and Critical Reporting, specifically focused on the clinical safety and performance of Medical Devices. These changes have either introduced new processes or altered existing ones for Medical Device Manufacturers.

CONFORMED With 15 years of experience in the Medical Device Certification sector and an expert team, we have made it our principle to stand by our Medical Device Manufacturers in every process, including this one.