[DIA Europe 2023] Implementing Significant Changes To DDC Products Under EU MDR

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Presented by

Andrew Gray, Amgen; Christelle Bouygues, EMA; Jonathan Sutch, BSI; Paul van Geffen, Deloitte; Shaik Rizwan, Novo Nordisk.

About this talk

The recent implementation of the MDR in Europe, specifically Article 117 for drug-device combination products, still presents challenges for manufacturers, Notified Bodies, and EMA, as additional clarity is needed related to submission content and the review process of significant changes requiring a Notified Body Opinion. This could be further impacted by the upcoming revision of the EU Pharmaceutical Legislation, which may include new approaches to combination product regulation in the EU. This session describes current challenges, proposed criteria for determining significant changes, and calls for additional clarity and proposed solutions on these issues, including upcoming guidance on this topic.
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