Navigating the Transition from MDD/IVDD to MDR/IVDR: A Complex and Costly Journey
For many companies with CE-marked products under the Medical Device Directive (MDD) or In Vitro Diagnostic Directive (IVDD), the transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) has become a challenging and costly process. What once was a straightforward regulatory pathway now feels like navigating a maze, with stricter…
