The 9th EAAR Annual Conference on New Medical Device Regulations (RMD 2025) will take place in Brussels, Belgium, on 24-25 February 2025, featuring speakers from across the MedTech industry, including regulators and notified bodies. Organized by the European Association of Authorised Representatives (EAAR), the conference serves as an inclusive platform for all stakeholders across the…

On 25 September 2024, Donawa Lifescience President Dr. Maria E. Donawa spoke at the webinar titled ‘Clinical Data Requirements: EU vs. US – Critical Differences and Strategies’. Dr. Donawa was joined as a speaker by Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, Trinity College, Dublin. The webinar was hosted by MedTech Leading Voice…

Donawa Lifescience President, Maria E. Donawa, M.D., has authored a second ‘Regulatory Recap’ article on LinkedIn covering interpretational difficulties with requirements for Clinical Evaluation Plans (CEPs) under the EU Medical Device Regulation (MDR, 2017/745) titled: ‘CEPs: What Does “State of the Art” Modify?’ The topic arises because of confusion among manufacturers, notified bodies, and competent…