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Notified Body Opinion (NBOp) Article 117 of the MDR: Challenges and Possible Ways Forward
Session Chair(s)
Thomas Wejs Møller, MBA, MSc
Director Global Regulatory Affairs - Devices
Novo Nordisk, Denmark
Published by the European Commission under the Medical Devices Regulation in 2017 and formally applied in 2021, Article 117 has added a new dynamic to the relationship between companies and Notified Bodies. Though it provides an important layer of protection, implementation has not been without controversy—leading to longer approval times, and increased costs for smaller businesses. This session will look to provide an overview of the challenges new innovations are facing due to cumbersome regulations, and explore how Notified Bodies, policymakers and industry can collaborate to provide a well-regulated environment which encourages progress.
Speaker(s)
Thomas Wejs Møller, MBA, MSc
Novo Nordisk, Denmark
Director Global Regulatory Affairs - Devices
Jonathan Sutch, PhD
BSI Group, United Kingdom
Principal Medicinal Technical Specialist
Tracey Burr, PhD, MSc
Ionis Pharmaceuticals, United States
Director, CMC Regulatory Affairs
Pascal Venneugues
European Medicines Agency, Netherlands
Quality Specialist, Pharmaceutical Quality Office
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