A pilot trial of the swissdamed database – an initiative designed to mirror the EU’s Eudamed – was successfully completed in June, allowing the regulator Swissmedic to confirm live implementation in January 2024. Work on two swissdamed modules is underway.
The Swiss authorities have made good progress in setting out the structures needed for the future Swiss Database on Medical Devices (swissdamed). This tool to regulate medtech in Switzerland was a provision of the national medical devices and IVD ordinances (MepV and IvDV).
A pilot project in June 2023 involved 17 companies who tested Module 1 (Modul ACT) on the registration of companies...
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
The medtech sector in the UK, Switzerland, and Germany face a challenging 2025, heads of national trade groups say. Competition and access to innovation remain key concerns across the board, with collaboration with the EU and US planned in Switzerland while Germany focuses on approaching elections.
Medtechs will be indirectly affected by a new law in Switzerland that unifies the amount of funding allocated to inpatient and ambulatory care.
An “NHS Innovator Passport” that allows quicker uptake of proven technologies across the national healthcare provider is one of the wins the UK government is looking to score from its new Life Sciences Sector plan. The plan majors on prevention. The medtech industry has given it a cautious welcome.
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
