One of the main concerns when planning towards compliance with Regulation (EU) 2017/745 on medical devices (MDR) is the clinical evaluation.
According to article 61 of the MDR, manufacturers must conduct a clinical evaluation to confirm the device’s conformity with the relevant general safety and performance requirements. The clinical evaluation shall be based on clinical data.
In the course of the MDR transition period, the Medical Device Coordination Group (MDCG) issued a number of guidance documents to help manufacturers interpret the MDR provisions in an appropriate manner. Still, even with these documents at hand, the clinical evaluation process remains complex and challenging.
bsi has issued a white paper recently that summarizes the requirements and guidance documents and describes its interpretation of the corresponding provisions. The 21-page document is a valuable tool to learn about the perspective of a notified body on this central aspect of the MDR.
Should you wish to have a copy of the white paper for your references, please don’t hesitate to get in touch.