Blog on Medical Device Regulation and CE Marking

CE marking for in vitro diagnostic devices under the IVDR

14.01.2023 Knowledge

CE marking for in vitro diagnostic devices under the IVDR

“Legacy” medical devices and IVDs under EU legislation

12.01.2023 Knowledge

“Legacy” medical devices and IVDs under EU legislation

Swiss authorised representatives for medical device manufacturers

11.11.2022 Knowledge

Swiss authorised representatives for medical device manufacturers

How to obtain a CE mark for a medical device

02.11.2022 Knowledge

How to obtain a CE mark for a medical device

Is my product a medical device in Europe? How to determine if your product requires medical device CE marking

16.09.2022 Knowledge

Is my product a medical device in Europe? How to determine if your product requires medical device CE marking

Class I medical device requirements for manufacturers under EU MDR

16.07.2022 Knowledge

Class I medical device requirements for manufacturers under EU MDR