4. Approval Process

In the European Union, the safety, performance and quality of medical devices is regulated by the Medical Devices Directives and Regulations, with specific regulations applied to the different classes of device. A device is supported by a medicine, and no marketing authorisation (MA) is required. If the device supports the effect of the medicinal substance it is considered a medicine and requires a MA.

*In 2021, a new regulation will be released by the European Commission and this lesson will be updated accordingly.