Effective today, August 6, 2024, the ‘’Actors’’ module of the Swissdamed medical devices database is…
Regulatory updates: January 2024
With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory…
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),…
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…
Swiss and EU relations: impact on medical devices
The agreement between Switzerland and the European Union on mutual recognition in relation to conformity…