EU

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.

Pharmaceutical industry says the transition from paper to electronic product information, as part of EU pharmaceutical reforms, should not be held back by member states' readiness.

Royal Philips is at the forefront of the driving environmental sustainability along the Scope 1-2-3 chain. The company hosted a round table in Amsterdam to hear experiences from providers.

ZS principal Brian Chapman tells In Vivo what is troubling the global medtech industry at the turn of 2025, and takes the opportunity to chide the EU for its persistent fixation on taking on the “problem that did not need to be solved.”

Medtech Insight spoke to eight well-known EU regulatory experts to find out what developments they expect to see, what they fear and their wish list for 2025.

Switzerland’s devices MRA with the EU is fully back on the agenda following a broader, historic EU-Swiss future trade deal agreed on 20 December. Additionally, Swiss Medtech is pursuing MDR improvements with EU counterparts, and the Swiss authorities will lay the ground in 2025 to permit US FDA-approved in Switzerland.

New documents on clinical investigation reports, how to apply to notified bodies and the process of submitting information about devices being discontinued feature among nine critical new documents published by medtech authorities in December 2024.

As application of the Health Technology Assessment Regulation nears, the European Commission has launched two new websites to help developers kick start the joint clinical assessment process and request a joint scientific consultation.

The EU regulatory framework is adequate for electronic product information, although work to develop certain aspects is required, according to a pilot report published by the European Medicines Agency.