It is confirmed. Switzerland adopted the new Regulation on In-vitro Diagnostics (IvDO), which mainly refers to the IVDR. The provisional text in Germa...
UKCA marking!
The new UKCA marking is required after July 1, 2023. Manufacturers should start acting now to ensure the deadline is met. When affixing the UKCA marki...
European Parliament votes in favor for MDR 1 year delay!
On Friday, April 17, 2020, the European Parliament approved to delay by one year the EU Medical Device Regulation with 693 votes in favor, 1 against a...