In this week’s roundup: Switzerland takes a step toward recognizing FDA approvals, the group implementing the new EU Health Technology Assessment Regulation elects leaders, and more European regulatory updates; FDA meets with CMS and others on early feasibility studies; a former BD employee petitions FDA; the World Health Organization issues 2022 “device atlas” report; and more.
Switzerland eyes FDA, HTA meet-up, and more from Europe:
Swiss aligning with FDA? Switzerland broke with the rest of Europe when its Parliament this week took the first step toward recognizing US FDA approval for making medical devices available in the Swiss market as an alternative to an EU MDR-aligned standard. The country has historically operated under mutual recognition agreements that allowed seamless implementation of EU regulatory frameworks, but those agreements broke down last year. With growing concerns about the EU Medical Device Regulation becoming overwhelmed by capacity issues, the Swiss device industry has urged reliance on FDA to help ensure continued patient access to devices. (See “Switzerland Breaks with Europe, Aligns With FDA as MDR Cliff Rapidly Approaches,” Market Pathways, December 1, 2022.)