Europe – May’s Regulatory Focus: EU MDR and EU IVDR update, and more

Feature articles during May focused on the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR). The 26 May deadline for the MDR has come and gone, and the regulation is now being fully applied after a yearlong delay because of the pandemic. Next up is the application deadline for the IVDR, now set for 26 May 2022. Articles in this issue examined the extent of preparedness among regulators, sponsors, and manufacturers for the two application deadlines, with specific focus on availability of resources (human and technological), access to notified bodies, and the ensuing time and cost implications for all parties…