EU Market Regulations Update – How to Manage Expiring Notified Body Certificates

The European Commission’s Medical Device Coordination Group (MDCG) has published a position paper covering the application of Medical Devices Regulation (MDR) provisions allowing legacy medical devices not yet certified under the new Regulation to remain on the European market for a set periods of time. This position paper addresses Article 97 of the MDR, which allows manufacturers and European Authorized Representatives to request that an EU Competent Authority (CA) permits legacy devices to remain on the market in that CA’s particular EU member state. 

The guidance opens up a new possibility to avoid shortages of medical devices in the EU and to take pressure from Notified Bodies. In this webinar, the presenter will help attendees develop a greater understanding of the time, effort and steps they need to take to determine whether they should apply for a decision based on Article 97 MDR, the most efficient road to success, and which other entities might need to be involved. The presenter will also share her experiences with submissions and best practices, including a discussion on evaluation information, as well as what lead CAs suggest you should provide when applying for Article 97 MDR.  

This webinar will give practical information and strategic insights on how to bridge possible gaps between your 93/42/EEC MDD, 90/385/EEC AIMDD certificate(s), and (EU) 2017/745 MDR certificate(s).  

Finally, during the webinar, the presenter will share the latest updates on the EC draft amendment to extend MDR and IVDR transitional provisions.  

About the presenter 

Annette van Raamsdonk, lead, quality, and regulatory affairs consultant, Emergo by UL 

Annette van Raamsdonk, LL.M. is the lead quality and 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, 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. Additionally, she advises manufacturers and other Economic Operators, as well as healthcare institutes on regulatory compliance and strategies, market access, Notified Body challenges, and more. Areas of expertise include European medical device legislation, borderline issues, classification of medical devices, Post Market Surveillance, and Competent Authority supervision.