The CORE-MD international Advisory Board chaired by Paul Piscoi (European Commission) met on 10 November 2021 for the first time. The Board includes medical device specialists from various sectors, public and private organisations and continents to complement and reflect on the project activities.
The first meeting focussed on (i) presenting the roots of CORE-MD, the regulatory environment in Europe, (ii) understanding methods used to generate clinical evidence for high-risk medical devices, (iii) requirements for real-world evidence and registries, (iv) artificial intelligence and machine learning in medical devices.
During the interesting academic discussion, advisors and project partners had the opportunity to exchange views and practices from Europe, Australia, US and Canada. Representatives amongst others agreed that there could be considerable overlap and synergies between the CORE-MD task on registries, and the development of registries for pharmaceutical products therefore it would be useful to share experience with the European Medical Agency (EMA). Infrastructures for keeping regulatory guidance and systems up-to-date will be needed. For example, a Registry Working Group at Commission level would be useful.
The Board will meet again in the second half of 2022. In the meantime, individual Board members might be consulted on specific issues that fall under their expertise as the project activities progress. Read the meeting summary below.