Description: For medical device manufacturers, achieving certification under the MDR can be a complex and lengthy process. The clinical evaluation is a, if not the most, important factor in this process, yet at the same time the requirements are not always fully clear. This is especially the case in less straightforward situations, such as medical devices enabled by AI/ML, those being considered for the Article 61(10) approach, and so-called “exempted” implantable devices. In this session, two speakers from Notified Bodies and a speaker with industry experience will shed light on Notified Body expectations for the clinical evaluation in these situations and a practical approach to fulfilling the requirements. Furthermore, it will be explored how the current developments in legislation, such as the proposed updates to the MDR, the AI Act and the digital omnibus, could impact clinical evaluation strategies. Relevant interaction between clinical evaluation and the AI Act and the newly proposed digital omnibus will be discussed, based on one of the speaker’s close experience with this topic as the chair of the standards committee expert group on AI in medical devices.
Learning Objectives:
Upon completion, participants will be able to describe the current state of play regarding the planned MDR update and changes related specifically to Article 61(10).
Upon completion, participants will be able to understand how the current AI Act, the intended modifications to the MDR, and the proposed digital omnibus interact in the context of clinical evaluation.
Upon completion, participants will be able to understand general aspects regarding a practical approach to clinical evaluation beyond clinical data, based on regulatory requirements.
