CORE-MD project was presented at the Regulatory Affairs Professionals Society in Amsterdam. Euro Convergence is the premier annual event for European regulatory professionals. This year’s event drew more than 500 participants from six continents and 33 countries. Attendees gathered for three days of education sessions, expert presentations and panel discussions curated exclusively by European regulatory leaders and focused on the most pressing topics in medical device, IVD and pharmaceutical regulation for the European market.
Presenters represented health authorities—the European Medicines Agency (EMA), the European Commission (EC), Swissmedic, the Austrian Medicines and Medical Devices Agency, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and the US Food and Drug Administration (FDA)—or notified bodies, such as BSI, TÜV SÜD, Dekra and Kiwa Dare.
Alan Fraser, CORE-MD Coordinator, was involved in the discussion and pointed to the work done by members of the CORE-MD Consortium to provide scientific recommandation on evidence for medical devices. He notably highlighted the ongoing activities on registries, artificial intelligence or methods to generate evidence. The expected contribution from CORE-MD to the wider regulatory community was much welcomed by participants given the challenge the implementation of medical device regulation represents.
For more information, please visit the conference’s website.
