News and Updates

The new regulation brings significant changes that will impact both manufacturers and healthcare professionals. Here are the key highlights: Gradual Implementation of Eudamed:  The Eudamed database, essential for transparency and traceability of medical devices, will be gradually implemented. This [...]

Attention to all companies with products regulated under Directive 98/79/EC: It is crucial to be aware of the latest regulatory updates affecting the validity of certificates issued by notified bodies. Effective from July 9, 2024, the following changes will come [...]

Swissdamed: The New Medical Devices Database in SwitzerlandWe are pleased to announce that the first module of the swissdamed medical devices database will be available online starting August 2024. This milestone represents a significant advancement in the regulation and transparency [...]

CMC Consulting Group, a leading holding company in regulatory affairs and medical devices, celebrates the tenth anniversary of its parent company, CMC Medical Devices, with the presentation of a new corporate image that reflects its evolution and growth. With [...]

Two new authorizations have been added to the EU MDR, bringing the total number of MDR Notified Bodies to 48! From the 9th till the 10th of May 2024, MTIC InterCert S.r.l. and Kiwa Belgelendirme Hizmetleri A.S. obtained the MDR [...]

The Federal Council has decided to amend the Medical Devices Ordinance (MedDO) to improve the safety of products without an intended medical purpose (media release dated 29 September 2023). Switzerland has adapted its MedDO for these products in line with [...]

The length of the new deadlines depends on the future IVDR risk class and whether a notified body has already been involved under IVDD. Interestingly, according to the current proposal, the EU has moved the original cut-off date from [...]