Medical devices and active implantable medical devices

On 26 May 2021, the European Medical Device Regulation (EU) 2017/745 (MDR) came into force. The MDR introduces a major update to the regulatory framework in the European Union and brings several changes to the scope of clinical studies to be submitted for approval, the initial submission processes and their substantial modifications, the content of the submission file and safety reporting.

As can be seen from the decision tree below, the study needs to be submitted to the appropriate regulatory pathway, depending on the type of medical device used in the study and the type of study.

More useful info on clinical research is available on the webpage of the FAMHP:

https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/clinical_evaluation/DM_AIMD

Last edit: 12 January 2023