ARTICLE SUMMARY:
In this week’s Pathways Picks: The European Commission launches a targeted evaluation of medtech regulations, notified bodies outline how device companies should seek MDR certification, and more EU updates; members of Congress unveiled an end-of-year funding bill including an array of healthcare reforms, but Trump opposition threatens government shutdown; lawmakers issue a report on AI; Australia drafts a UDI guidance; and more from the US, UK, and South Africa.
Editor’s note: Pathways Picks will be taking a break for the next two weeks, and will return to your inboxes on January 8. To our readers: happy holidays and all the best for a successful start to 2025!
EU Picks
MDR in the mirror, consensus building, device sampling and more:
Evaluating the MDR and IVDR. The European Commission launched a consultation December 12 to inform its “targeted evaluation” of the Medical Device and IVD Regulations, an effort that is anticipated to support a MDR/IVDR legislative reform proposal. Input from industry and other stakeholders is due March 21, and EU commissioners have promised to complete the evaluation sometime next year, followed by an impact assessment. “The evaluation will look ... at how effective the rules are and at the costs and administrative burdens of the rules, especially for [small and medium-sized enterprises], and at the benefits for patients and users,” the Commission said. It will also address the impact of the regulations on device availability, orphan devices, and “innovative” devices.
