Clinical investigation - any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
Performance study - a study undertaken to establish or confirm the analytical or clinical performance of a device.
National regulation on medical devices is the Regulations No.455 of the Cabinet of Ministers of Latvia, adopted August 15, 2023 “Procedures for conducting clinical investigations on medical devices and performance studies on in vitro diagnostic medical devices for human use”
The Regulation No.455 implements obligations of the Regulation (EU) 2017/745 on medical devices and 2017/746 on in vitro medical devices of April 5, 2017.
National regulation defines:
- the structure, functions, and procedures for delivering an opinion of the Ethics Committee,
- the procedures for the authorisation of a clinical investigation and performance study,
- the duties and responsibilities of the parties involved (sponsors, investigators),
- the protection of the subjects participating in a clinical investigation and performance study,
- the monitoring and reporting requirements.
