EU

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.

The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.

The estimated costs to the pharmaceutical and cosmetics industry of introducing a fourth level of urban wastewater treatment are unclear, with the European Commission’s estimate of €1.2bn in dispute.

Assimilated EU medtech law used in Great Britain will not be sunsetted on 26 May 2025, as originally provided for. That was the first decision published by the MHRA in the wake of its recent consultation on shaping the regulatory system.

Some changes to the contentious social security financing bill have been made, but industry and the government remain at odds over a €1.2bn drugs overspend.

Improving reimbursement and integrating digital process across health care should be two priorities for the incoming German coalition, says Martin Walger, chief executive of the IVD industry association, the VDGH, in part two of his interview with In Vivo.

Notified bodies’ conformity assessment processes can easily be streamlined and made potentially less costly within the context of the EU’s current regulations.

The MHRA’s post-market surveillance regulations for Great Britain will be followed in 2026 by a pre-market regulation, but its progress will not be steered by the agency’s erstwhile leader of device system transformation. The ABHI’s Steve Lee and Phil Brown ponder where national device system regulation – and the MHRA – go next.

Cardiovascular detection and pharmacy legislation were put on hold last November when Germany's federal election was called. Martin Walger, chief executive of the IVDs industry association, the VDGH, discusses the hopes and fears of IVD companies in the run-up to the February 2025 vote.

While the main deadline for the application of the EU’s AI Act to most AI-enabled medical technologies already regulated under the medtech regulations is 2 August 2027, various more immediate deadlines also need meeting.