The European Commission and the Swiss Confederation announced on 18 March the start of negotiations…
Regulatory updates: January 2024
With the start of 2024, the EU, UK, and Swiss competent authorities provided new regulatory…
US and EU regulatory systems for medical devices in comparison
Switzerland relies significantly on imported medical devices. With the implementation of the EU Medical Devices…
Swissdamed: roll-out plan of the Swiss database on medical devices
Like the European Union, also Switzerland implemented the obligation to register medical devices and IVD…
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),…
Swissdamed: Database for Medical Devices in Switzerland
In Switzerland, Swissmedic enforces the registration of economic operators and medical devices. For this purpose,…
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…