Final Coverage-With-Evidence-Development Guidance Delayed By CMS Staff Cuts

Nearly one year into leading their agencies, US FDA Commission Marty Makary and CMS Administrator Mehmet Oz took to the stage together at the Milken Institute’s Future of Health Summit 2025 to highlight what they see as progress and lay out plans for the road ahead.

Stay current on regulatory guidelines from around the world with Medtech Insight’s Guidance Tracker. Over 60 documents have been posted on the tracker since its last update.

The roles and responsibilities of EU medtech’s persons responsible for regulatory compliance vary widely in role and risk exposure. The recent TEAM-PRRC meeting highlighted how vulnerable they can be and the steps to protect themselves.

The EU’s Medical Device and IVD Regulations require every manufacturer and authorized representative to have a PRRC. As compliance becomes mandatory for increasing numbers of manufacturers, figures are soaring and this role is becoming both increasingly distinctive and more complex.