EU

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.

LFH Regulatory managing director and founder Laura Friedl-Hirst tells Medtech Insight what was piquing the interest of medtech companies visiting her company’s stand at Medica 2024.

Cancer retained its crown as 37 novel drugs were approved for pan-EU marketing last year; treatments for blood disorders followed closely behind in what was another slow year at the European Medicines Agency.

The European Commission has issued a report on the protectionist medtech policies in China that are impacting imports and is considering measures to protect EU manufacturers.

The UK market has become tougher for smaller innovators, says Andy Mears, CEO of Deltex Medical, which plans to launch a new iteration of its minimally invasive ultrasound-based technology, the oesophageal Doppler monitor. He explained how market access challenges have steepened.