Principal Consultant Medical Device Project B.V. Alphen aan den Rijn, Zuid-Holland, Netherlands
Description: It is of paramount importance for a manufacturer to realize what the expectations of the Notified Body are, on using only non-clinical test data when demonstrating compliance to the general safety and performance requirements (GSPR) from Annex I of the Medical Devices Regulation (MDR). In this session, we will discuss several pitfalls to avoid when using article 61.10. Article 61.10 should never be interpreted to be a loophole to avoid collecting clinical data, and an adequate justification should always be present. Also, testing to prove equivalency should not be confused with applying article 61.10. Based on real-world example devices, it will be outlined in which cases it might be appropriate to rely on non-clinical test data only. Furthermore, an overview will be given on the requirements for a clinical evaluation report using non-clinical data only. Several points for further discussion will be raised, such as the concept of level of patient benefits to help determine the required type of testing and the application of post-market clinical follow-up for devices falling under article 61.10. After this session, the meaning and application of article 61.10 will be a bit more clarified and common pitfalls can be avoided. Food for thought will be provided as to whether your device might fall into this category of devices and how to proceed with your clinical evaluation.
Upon completion of this session, participants should be able to: Substantiate whether article 61.10 is applicable to their devices and recognize when article 61.10 should not be used.
Upon completion of this session, participants should be able to: Know how to proceed with an article 61.10 device and to establish a sound clinical evaluation report using non-clinical data.
Upon completion of this session, participants should be able to: Avoid pitfalls related to article 61.10 and know on which aspects interpretation of the Regulation is still uncertain.