ARTICLE SUMMARY:
In this week’s Pathways Picks: The Council of the European Union recommends changes and urges quick action on MDR/IVDR reforms; FDA and UK regulators embed liaisons to improve collaboration; CMS proposes expanded TAVR coverage; and more from Europe, the US, and Asia.
EU Council Weighs Reforms
Health ministers push for changes and quick action on MDR/IVDR reforms:
European health ministers convening this week generally expressed support for proposed legislative reforms to the EU Medical Device and IVD Regulations. But the national leaders also signaled areas that are going to require negotiation before the measures can be approved. The Council of the European Union, which represents EU member state leadership in the Union’s legislative process, held a hearing of its healthcare segment (Employment, Social Policy, Health and Consumer Affairs Council) on June 16.
The session included discussion of the MDR/IVDR reforms proposed in December by the European Commission to streamline and harmonize enforcement of the regulations. Most of the ministers stated during the hearing that they support the reforms and want to find quick consensus. The rotating presidency of the Council will shift from Cyprus to Ireland on July 1; several health ministers pressed to complete MDR/IVDR negotiations before the Irish presidency ends in December. “We encourage the incoming presidency to reach a swift conclusion on this file. You have our full support,” said Wille Rydman, Finland’s Minister of Social Affairs and Health.
More work needed. There were also signs during the hearing of substantive disagreements that persist in closed-door negotiations. “Significant progress has been made by the presidency, but much work still lies ahead,” Belgium’s Frank Vandenbroucke stated. The Czech Republic and Poland were the only two countries that cited specific concerns during the hearing. The Czech minister said his delegation disagreed with the procedures introduced in the reforms entrusting national competent authorities with resolving disputes between manufacturers and notified bodies. The Polish representative said they wanted more focus on cybersecurity requirements in the regulations. More areas of disagreement, however, were highlighted in a “progress report” published in conjunction with the hearing that did not link specific comments with specific country delegations. Some of the concerns included:
- Multiple countries have taken to heart the criticisms from notified bodies that proposals to remove some of their assessment responsibilities during premarket and postmarket phases threaten patient safety. “Several delegations identify certain regulatory gaps and remain cautious regarding the cumulative impact of some of the simplifications proposed by the Commission,” the progress report notes.
- Some ministers are elevating concerns from notified bodies about provisions that would force them to reduce fees for small device firms. “Several delegations consider that the reductions on the fees to be paid by micro and small manufacturers for conformity assessment activities, may put at risk the financial sustainability of notified bodies, especially those that are SMEs themselves, and question the empowerment for the Commission to set the level and structure of notified body fees,” the report notes. (Notably, on June 16, TEAM-NB, which represents notified bodies, issued a position paper outlining why fee reductions are counter-productive, and how other steps to improve capabilities, flexibility, and predictability would bring greater benefits to small device companies.)
- There are calls for more clarity in delineating the roles of the European Medicines Agency and the Medical Device Coordination Group and regarding the competent authorities’ new responsibilities for ensuring devices are clearly classified.
- There is support for a provision that would fully move oversight of AI-enabled devices under the MDR/IVDR (rather than the AI Act), but some of the delegations want more explicit requirements for AI technology in the sectoral regulations.
What’s next. Cyprus made clear earlier this year that it was collaborating closely with Irish leaders to ensure a seamless handoff to support quick action, but no precise timeline to complete Council negotiations has been identified. The EU Parliament is working on the issue in parallel, with plans to vote on an MDR/IVDR reform bill in early 2027. Once both the Council and Parliament reach their own compromises, the two bodies must engage with the Commission in formal “trilogue” negotiations to reach a final agreement that can be enacted.
