ARTICLE SUMMARY:
In this week’s Pathways Picks: A debate over the proper speed of EU MDR/IVDR reforms; FDA’s device center issues its FY 2025 guidance priorities, and it posts new details on device trial demographics; EU and ISO actions on standards; progress toward a "breakthrough" Medicare coverage bill; Japan regulator PMDA plans to open up its first office in Washington DC; and more from FDA and the International Medical Device Regulators Forum.
Updated October 16 with briefs on the prospects of a “breakthrough” Medicare coverage bill, Japan’s plans to open as DC office, and FDA’s JAMA publication on AI regulation.
Top Picks
Planning for EU reform and FDA guidance:
Push and Pull on EU reforms. While the medtech industry and its supporters in the European Parliament are pressing for urgent action to reform the EU Medical Device and IVD Regulations, influential clinician and research groups are urging a more cautious approach. The European Commission is conducting a comprehensive MDR/IVDR evaluation expected to wrap up by the end of 2025, members of Parliament (MEPs) used an October 9 debate session to call on the Commission to speed up its efforts and make comprehensive reform proposals within the first 100 days of the upcoming second term of the Commissioner (set to start before the end of the year). MedTech Europe then signed on to an October 14 statement with other industry associations that acknowledged the end-of-2025 timeline as a catalyst for a broader set of reforms, but pushed for speedier action on “bridging measures” to reduce time and cost of certifying devices, improve efficiency of device modification reviews, and adapt certification to “follow a life cycle approach.”
A consortium of European clinician and research groups, however, has also weighed in, imploring EU policymakers not to rush efforts to reevaluate and propose reforms to the MDR and IVDR. “A careful review of the regulatory framework for medical devices and in vitro diagnostics cannot effectively be conducted in such a short time period,” the Biomedical Alliance in Europe argued in an October 9 statement, referring to the 100-day demand from MEPs. The alliance, which represents 35 medical and research societies, allowed that targeted changes to address pressing issues, in particular the limited availability of orphan and pediatric devices, can be pushed through more quickly, but otherwise, it said, any proposed changes must be carefully analyzed to ensure they don’t have unintended consequences. MEP Peter Liese, from Germany, has circulated a comprehensive MDR reform plan that would add a new governance structure and streamline recertification procedures and certain postmarket reporting obligations, among other updates. But some of these changes, the alliance argued, are “not supported by any rationale or impact assessment to consider the public health consequences. In addition, the group’s suggest, proposed reforms do not necessarily address the “single greatest” cause of dysfunction in the regulations: “In simple terms, it is not clear whether a technology requires a clinical study, or how that study should be designed.”
