en
Dictionary:

Specific rules for medical devices

Please note that as from 26 May 2021, new rules for clinical studies involving medical devicesexternal link will apply.

Registered with the Medical Products Agency

Some clinical studies involving medical devices must be registered with the Medical Products Agency. Information on how to register is available on the Medical Products Agency’s website, which also has a summary of the regulations and guidance documents that apply for studies involving medical devices.

Register a clinical study and regulations for clinical studies involving medical devicesexternal link, opens in new window