Noticias y novedades
CMC Consulting Group celebrates tenth anniversary of CMC Medical Devices with a new corporate image
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 [...]
NEW Notified Bodies obtained the MDR audit qualification
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 [...]
Revision of MedDO and IvDO
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 [...]
How long are the transition periods for IVDR?
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 May [...]
