Watch now: Regulation EU 2023/607 frequently found issues
In this webinar, the presenter outlines the latest insights about Regulation EU 2023/607, including making use of the extension and what documentation to keep.
Jan. 18, 2024
Annette van Raamsdonk, lead quality & regulatory affairs consultant, Emergo by UL
The European Commission amended the Medical Devices Regulation (EU) 2017/745 (MDR), Article 120. This was done through adoption of Regulation (EU) 2023/607 on March 20, 2023. Regulation (EU) 2023/607 introduces a staggered extension of the transition period provided for in the MDR under certain conditions. Also, the sell-off deadlines in both the MDR and IVDR have been removed with the adoption of this Regulation; previously, before the amendment was made, devices placed on the EU market and still in the supply chain but not yet put into service would have to be withdrawn after the sell-off deadline passed.
This webinar will help you gain a better understanding of what action you will need to take and when so that you can make use of the extension under Regulation (EU) 2023/607. You will learn which documentation will need to be kept ready for Competent Authorities and Economic Operators (such as the EU Authorized Representative) to ensure manufacturers can justify their legacy devices can remain in the market during the extended transition period.
About the presenter
Annette van Raamsdonk, LL.M. is the Lead Quality & Regulatory Affairs Consultant at Emergo’s office in The Hague. 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.