Clinical investigations are necessary when the performance and safety of a device can only be assessed through trying out the device on a human subject. (The term ‘clinical investigations' is used in the EU, whilst ‘clinical trials' is used in the USA. In the EU the term ‘clinical trials' is reserved for drugs.)
 
Naturally there are strict controls governing clinical investigations. These are implemented on a Member State by Member State basis. There is no ‘blanket' EU-wide authority for clinical investigations. Controls on clinical investigations are enforced by the Competent Authorities, and not the Notified Bodies. Clinical investigations for in vitro diagnostic medical devices are called Performance Evaluations.

Priory Analysts is able to assist a manufacturer in setting up and conducting Clinical investigations so that they follow requirements of the Medical Device Directives and other regulatory guidance. We usually supply this service in cooperation with Associates.
This service is called Tech-paCE