Blog on Medical Device Regulation and CE Marking

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

Swiss authorised representatives for medical device manufacturers

07.07.2022 Knowledge

Swiss authorised representatives for medical device manufacturers

Swiss medical device importers – regulatory requirements

27.06.2022 Knowledge

Swiss medical device importers – regulatory requirements

Risk Management for Medical Devices under EU MDR and ISO 14971

19.05.2022 Knowledge

Risk Management for Medical Devices under EU MDR and ISO 14971

Which MDR requirements apply to distributors of medical devices?

23.03.2022 Knowledge

Which MDR requirements apply to distributors of medical devices?