Clinical Investigation Management for Medical Devices according to MDR

Key elements of the MDR and IVDR are the significant reinforcement of the risk classification, conformity assessment procedures, performance evaluation and performance studies, vigilance, and market surveillance while ensuring transparency and traceability. The specific requirements of the documentation for MDR are set in the main body and annexes of Regulation (EU) 2017/745. The clinical evaluation of a medical device should be performed through a clinical investigation that will be performed in accordance with the ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice. These studies should be performed after obtaining an Internal Review Board approval. In order to apply for approval of such as study, the application forms should accompany Clinical Investigation Plan and Investigator’s Brochure.