EAAR RMD Conference 2024 on regulations of medical devices, Brussels 26 – 27 February

Dr. Luc Van Hove participates, as representative of the European Authorized Representative (EAR) Silimed BV NL  at the European Association of Authorized Representatives (EAAR) in the RMD Conference in Brussels, 26 – 27 February. The conference is focused on industrial challenges and key regulatory developments for medical devices that are important for Authorized Representatives to know. Of particular interest are the sessions on the latest developments on the MDR and IVDR regulations and the EMA role in the MDR/IVDR framework for combination products. Additional national requirements beyond the MDR and IVDR will also be highlighted. Positive and negative experiences with the Notified Bodies will be discussed. Legal aspects of the MDR and IVDR will be reviewed and the potential impact of AI will be assessed. Of particular interest to MARACA International are the sessions on Clinical evaluations and scientific validity as their pain points will be reviewed. Also of interest are the discussion of a practical approach to postmarket surveillance and vigilance requirements. Last but not least, the status of the EUDAMED database will be presented.