Manufacturers call for a reasonable implementation timeline to align their procedures, tools and infrastructure for Eudamed readiness and for various pre-conditions to be met.
A group of EU medtech industry associations, including MedTech Europe, have sent a joint open letter sent to the European Commission calling for important preconditions to be met before any modules of the European medical devices database, Eudamed, are made mandatory.
This letter follows a few weeks after calls at the 30 November meeting of the Employment, Social Policy, Health and Consumer Affairs Council, for early availability, on a mandatory basis, of the Eudamed medical device database
While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.
Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
