Annette J. van Raamsdonk

Lead Quality & Regulatory Affairs Consultant, Emergo by UL – Netherlands

Annette van Raamsdonk, LL.M. is the Lead Quality & Regulatory Affairs Consultant at Emergo’s office in The Netherlands. She gained significant experience with a broad variety of medical devices working at TÜV Rheinland and serving as Inspector of Medical Technology at the Dutch Youth and Healthcare Inspectorate (IGJ). She represented the IGJ within the European Competent Authorities working group for Compliance and enforcement. Currently, she is the lead of the European Authorized Representative service, acts as the Person Responsible for Regulatory Compliance (PRRC) for Emergo Europe, is the contact person for European Competent Authorities, vice-chair of the European Association of Authorized Representatives (EAAR) and takes part in several European Commission working groups, addressing regulatory questions/issues related to the MDR. Aside, she advises manufacturers and other economic operators, as well as healthcare institutes on regulatory compliance and market (access) strategies, market access, Notified Body challenges and support, and more. Areas of expertise include European medical device legislation, borderline issues, classification of medical devices, Post Market Surveillance, and Competent Authority supervision. As one of her side activities, she is a board member of RAPS Netherlands and Belgium.