Dr. Luc Van Hove from MARACA International participates in the worldwide regulatory professionals’ RAPS convergence in Vancouver, Canada on 1-4 October to discuss the latest advances in regulatory affairs. He will review in particular progress of SME transition efforts to the new MDR. He wil alert that it is already very difficult for SMEs to find a Notified Body to review their design dossier for certification. Having sufficient clinical evidence for their medical devices is the other hot topic. He strongly recommends SMEs to start PMCF studies now to have sufficient clinical data in support of their design dossier.