Razel Cada

By Razel Cada, Beth Pugh and Evangeline Loh The regulator in Switzerland, Swissmedic, continues to advance development of the Swiss Database on Medical Devices, Swissdamed: ACT module (registration of economic operators), a publicly accessible platform, and UDI module (registration of devices). Most recently (August 18), Swissmedic shared a revised timeline for Swissdamed compliance and announced the availability of the UDI Devices module.

By Razel Cada, Megan Gottlieb and Evangeline Loh Regulators are scrambling to confirm that their provisions regarding leveraging CE Marking Certificates are sufficiently aligned to Regulation 2023/607 by the May 26, 2024 deadline. Regulation 2023/607 Regulation 2023/607 amended the EU Medical Devices Regulation (2017/745, MDR) to grant more time for legacy medical devices to become compliant with the MDR. The first deadline is swiftly approaching, May 26, 2024.

By Razel Cada, Karen Hill, and Evangeline Loh Aspects of the Swiss medical device regulatory system (Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219)) leverage compliance with aspects of the EU legislation.