EU Legislative Reform

Simultaneous revisions of the EU’s AI, data and medtech rules offer opportunities for simplification and alignment but also risk confusion and competing priorities. With political tensions in the background, does all this portend further unwanted compromises or delays for medtech?

While anticipation grows around the European Commission’s forthcoming medtech proposal, due in mid-December, a series of EU documents have been published on topics including recertification, standards, changes to companion diagnostics and the latest notified body announcements.

Stakeholders have served up bold ideas - and familiar frustrations - in the EU’s latest MDR and IVDR consultation, giving the European Commission much to reflect on.

Finalized EU pharmaceutical legislation must ensure that patients are fairly represented in regulatory decision making, according to patient and industry experts.

EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.

Revision of the EU’s pharmaceutical legislation will include a new definition of unmet need, but getting it wrong could have unintended consequences for pricing and reimbursement.

Recent key updates include new guidance on trend reporting, classification decisions, and opportunities for industry.

Ireland, which according to industry experts has an “outsized” voice in representing the pharmaceutical sector, is set to take over the presidency of the Council of the European Union next summer.

MedTech Europe, along with 34 national associations active in the medical devices sector, is urging immediate and long-term action to strengthen the EU’s medical technology regulatory framework.

Fresh momentum is building across Europe’s medtech landscape, as regulatory reforms begin to align with the pace of innovation. But for start-ups and SMEs to thrive, supportive structures and early compliance tools are essential.

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.

But they also respond to opportunity to offer practical suggestions for the future.