#16 - Are you EU MDR ready?

Final versions of the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (IVDR) go into effect May 2020 and 2022, respectively. These regulations, alongside the already launched U.S. Food and Drug Administration (FDA) unique device identification (UDI) ruling, have impacted how medtech companies develop and market products for use and distribution. Even with seven notified bodies and counting, manufacturers remain concerned with the looming compliance deadline. A recent statement from the European Commissioner for Health emphasized the May 26, 2020, MDR deadline holds, despite any postponement of the EUDAMED database.