January 2025

New year starts with amendment of Swiss In Vitro Diagnostic Medical Device Ordinance (IvDO) in order to restore euqivalence to EU IVDR (EU 2017/746). It includes: – Extension of tranisitional provisions for medical device certification – Permanent simplification of mandatory labelling for devices dispensed by professionals – Product registration obligation enters into force at 1st […]

Manufacturers are obliged beginning from 10th January 2025 to notify authorities in case of discontinuation or interruption of supply of certain medical devices. Which devices? All models or types of devices, placed on the Union market and for which it is reasonably foreseeable that a supply interruption or discontinuation could result in serious harm or