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.
The NHS 10-Year Plan officially released on July 3 will crystalize NICE’s Rules-Based Pathway – a new concept for medtech evaluation that will come with a guarantee of funding – but only for a select number of products. Government to also introduce “innovator passport” to speed innovation into NHS.
“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
