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Combination Products Under Article 117 of the MDR – Alignment on Strategies for Building an Innovative Regulatory Environment in the EU
Session Chair(s)
Thomas Møller, MBA, MSC
Senior Director Global Regulatory Affairs - Devices
Novo Nordisk, Denmark
Article 117 of the Medical Device Regulation (MDR) is a complex regulatory pathway for approving integral drug-device combination products. Approval of drug-device combination products requires the involvement of Notified Bodies, and EMA providing additional layers of scrutiny. Moreover, changes to combination products under Article 117 present challenges due to a lack of consistency and predictability. The intricate interplay between pharmaceutical and medical device regulations under Article 117 creates uncertainties, contributing to regulatory burdens and hindering the efficient market entry of combination products. This session will convene relevant stakeholders to discuss the challenges associated with Article 117 and collectively develop perspectives aimed at addressing these issues in the EU.
Speaker(s)
Specific Challenges Identified
Michael Kühler
Bayer AG, Germany
Senior RA MD Expert
Panel Discussion:
Paul Piscoi
European Commission (EC), Belgium
Scientific Policy Officer
Panel Discussion:
Christelle Bouygues, PHARMD
European Medicines Agency, Netherlands
Senior Regulatory Affairs Officer
Panel Discussion:
Jonathan Sutch, PHD
BSI Group, United Kingdom
Principal Medicinal Technical Specialist
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