Provisions concerning clinical investigations conducted to determine the safety and performance of medical devices and in vitro diagnostic medical devices have been set out in:
- Chapter VI and Annex XV to the MDR,
- Chapter VI and Annex XIV to the IVDR, and
- Chapter 3 of the Medical Devices Act 719/2021.
Clinical investigations can be conducted throughout the entire lifecycle of a device. Manufacturers of medical devices conduct investigations before placing a device on the market and as part of post-market clinical follow-up. Academic researchers and start-ups also conduct clinical investigations involving medical devices.
The following pages contain information about the notification and application process for clinical investigations of medical devices and IVDs and the processing of applications by authorities.
A sponsor cannot submit an application for a clinical investigation or a substantial modification to an investigation to Fimea before the regional ethical committee has provided its opinion on the investigation.
Clinical investigations of medical devices
Performance studies of IVD-devices