EU Legislative Reform

If medtech regulation is to work for patients, industry and society, Europe must move from political positioning to evidence-driven policymaking. It is time to avoid repeating the self-destructive cycle.

The European Commission’s proposal does not envisage a single centralized medtech agency, but instead sets out a targeted redistribution of tasks that could strengthen the existing framework. Professor Tom Melvin told Medtech Insight how.

Could the understaffing that has weighted down EU’s medtech regulators become a thing of the past?

European Commission-sponsored study published in December reveals the full impact of soaring compliance costs, shrinking device portfolios and innovation shifting abroad.

Proposal Gives Unrealistic Timelines And Reflects Poor Grasp Of Notified Body Realities

MedTech Europe’s Petra Zoellner discusses industry's response to EU regulatory proposals aimed at improving notified body operations, transparency, and cost predictability, ultimately fostering innovation in medical technology.

Industry associations support the commission’s MDR/IVDR revision simplification objective and aim to increase Europe’s competitiveness, but MedTech Europe also sees further room for improvement.

The just published proposed targeted revision of the Medical Device and IVD Regulations is a radical rethink of how the EU should regulate medical devices. The document is aimed at supporting industry and patients alike.

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.