ARTICLE SUMMARY:
In this week’s Pathways Picks: EU lawmakers get started on MDR/IVDR legislative reforms; the US EPA proposes loosening ethylene oxide sterilization standards; FDA finalizes weight-loss tech guide, plans new adverse event database; China outlines unique device identifier expansion; the AMA reports accelerating AI use in the US as the EU advances AI Act reforms; and more global updates.
Top Picks
EU legislators look at MDR, US to loosen EtO rules:
MDR legislative work begins. The EU Parliament and Council are just starting work on the European Commission’s proposals to comprehensively reform the MDR and IVDR now that translated texts are ready. Leaders from both bodies say they know quick work is needed, but warn the process is unpredictable. For more in Market Pathways see, “EU Lawmakers Pledge to Prioritize Device Reforms, But Don’t Commit to Timing.”
EPA reopens sterilizer rule. The US Environmental Protection Agency is proposing to loosen heightened ethylene oxide (EtO) emissions standards for commercial sterilizers established in 2024 under the Biden administration. Device manufacturers depend on EtO to sterilize a significant swath of products but the gas is associated with elevated cancer risks, setting up a debate around relative health risks of reducing EtO emissions but threatening device supplies. The Trump administration had already delayed implementation of the stricter standards from 2026 to 2028 for about 40 sterilizers. Now a March 12 proposed rule would rescind some of the requirements and revise others to remove barriers that sterilizers and device firms have said could inhibit production.
