CE/MDR 에서의 Clinical Investigation 임상시험의 정의는 다음과 같습니다.

MDR Article 2 Definitions

(45) Clinical Investigation - any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device

임상시험에 대한 내용은 Clinical Article 72 - Conduct of a clinical Investigation 에서 확인 할 수 있으며 아래와 같습니다.

1. The sponsor and the investigator shall ensure that the clinical investigation is conducted in accordance with the approved clinical investigation plan.
2. In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the clinical investigation is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a clinical investigation. The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the clinical investigation including the following:
   1. the objective and methodology of the clinical investigation; and
   2. the degree of deviation of the intervention from normal clinical practice.
3. All clinical investigation information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection.
4. Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves transmission over a network.
5. Member States shall inspect, at an appropriate level, investigation site(s) to check that clinical investigations are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the investigation.

현재 진행중이거나 완료된 임상시험은 다음의 사이트에서 확인할 수 있습니다.  https://clinicaltrials.gov/
앞으로  MDR에서는 Article 73의 내용처럼 Electonic System으로 EUDAMED 를 구축할 예정입니다.

해당 사이트에서 찾고자 하는 질환 또는 증상으로 검색하면 상태별로 Not yet recruiting, Recruiting, Suspended, Terminated, Completed, Withdrawn 등으로 확인 가능하며, 각 시험 별 Sponsor, Safety 및 Performance, Serious Adverse Events 등을 확인할 수 있습니다.