The 8th EAAR Annual Conference on New Medical Device Regulations (RMD2024) took place in Brussels, Belgium, on 26-27 February 2024, featuring speakers from across the MedTech industry, including regulators and notified bodies.

Organized by the European Association of Authorised Representatives (EAAR), the conference served as an inclusive platform for all stakeholders across the both medical device and IVD landscapes. With a dedicated focus on the challenges faced by manufacturers and other stakeholders in embracing the EU MDR and IVDR, the event invited attendees to delve into the depths of European regulation, fostering insightful discussions on pivotal facets of these ever-evolving regulatory frameworks.

Donawa Lifescience President, Maria E. Donawa, M.D., spoke on the second day, covering two topics, these being ‘Development of an ISO Standard on Clinical Evaluation’, and ‘Clinical Evaluation Documentation: Pain Points and How to Approach them’.

The conference also provided opportunities for one-on-one meetings with the speakers and event organisers.