Description: In this session we will explore different approaches to clinical data acceptance in the EU with a specific focus on the high-risk medical devices and challenges to balance the benefit of early access to technology with risks of unknown long-term safety and performance, and particularly how it is leveraged for the MDR.
Recently, Europe conducted comprehensive research on this subject under umbrella CORE-MD multi-stake holder initiative as well as dedicated MDCG Task Forces.
Policy framework including updates to the MDCG guidance on clinical evaluation is under development, MDCG guidance on clinical evaluation of Orphan Devices has been just published.
How to start applying this knowledge and guidance enabling access to innovation and ensuring patent safety?
