A clinical evaluation of a medical device shall mean a process the purpose of which is to critically review clinical data and evidence the safety and efficacy of the investigational medical device used as intended by the manufacturer in typical conditions of its use.
Clinical data shall mean information on the safety or efficacy which is implied by the use of the medical device.
Clinical data are obtained from:
- One or more clinical investigations of the investigational medical device;
One or more clinical investigations or other studies referenced in professional literature pertaining to a medical device for which adequacy with the investigational medical device has been evidenced; or
Published or non-published expert reports on the use of the investigational medical device in clinical practice, or on the use of a properly CE-marked medical device for which adequacy with the investigational medical device has been evidenced.
A clinical investigation shall mean the usage of the medical device in trial subjects in the process of systematic testing at a provider’s of healthcare services with the objective to:
Demonstrate whether the investigational medical device is suitable for use in compliance with its intended purpose, particularly in terms of its safety and efficacy;
Establish the effects of the investigational medical device upon the trial subject; and
Specify side effects of the investigational medical device and evaluate whether these pose acceptable risks.
A multicentric clinical investigation shall mean a clinical investigation conducted in compliance with a single clinical investigation plan at more than one professional site by more than one investigator.
Clinical investigations must be conducted in compliance with the Declaration of Helsinki.
In the sphere of clinical investigations, the Institute shall:
- Register sponsors of clinical investigations;
- Authorise the conduct of a clinical investigation of a medical device;
- Issue its approval of changes to the medical device clinical investigation dossier;
- Decide on suspension or termination of a clinical investigation;
- Maintain and publish, in a manner allowing for remote access, a list of healthcare service providers who have established an ethics committee;
- Record Serious Adverse Events (SAE) notified by the sponsor;
- Safeguard the forwarding of information on clinical investigations to the European Database on Medical Devices (Eudamed).