In August 2025, Swissmedic announced to adopt the new EU requirements on eIFUs with immediate effect. With this alignment, it is possible to use electronic…
Swissdamed device registration module is now available
In August 2025, Swissmedic announced the new UDI Devices module in Swissdamed is live. The registration is voluntary and will become mandatory only in July…
Swiss Federal Council votes in favour of IvDO amendments
On 20 November 2024, the Swiss Federal Council voted in favour of certain amendments to the Swiss IVD Ordinance. The changes address various aspects, from…
Actors can now register to Swissdamed!
Effective today, August 6, 2024, the ‘’Actors’’ module of the Swissdamed medical devices database is active! Manufacturers, importers, authorised representatives can now register through the…
Regulatory updates: January 2024
With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory documents. In this post, we will provide an overview of…
How MDCG 2022-18 applies in Switzerland: certification gaps and notification
Following the Council’s agreement on the new measures to implement the Medical Devices Regulation (MDR), the Medical Device Coordination Group (MDCG) published a position paper…
EU IVDR v. CH IvDO: How are In Vitro Diagnostic Medical Devices regulated on the Swiss market?
The end of the Mutual Recognition Agreement On May 26, 2022, the new Regulation 2017/746 (IVDR) repealed Directive 98/79/EC on in-vitro diagnostic devices (IVDD), which…
Swiss and EU relations: impact on medical devices
The agreement between Switzerland and the European Union on mutual recognition in relation to conformity assessment (MRA) of medical devices started in June 2002 and…