Medical Device

A clinical investigation is a systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.

Clinical investigations shall be performed on the basis of an appropriate investigation plan that is reflecting the latest scientific and technical knowledge. The investigation plan shall be designed to demonstrate whether the device is safe and achieves the performance intended as claimed by the manufacturer and that the benefit of the device outweighs the risks.

Clinical investigations should follow ISO 14155

Other products for clinical testing:

• Functional food
• Nicotine containing products