New sections include the basic requirements for combination products and the selection of a notified body. Further topics consider the impact of MDR on a Mutual Recognition Procedure (MRP) and the applicability of unique device identifier (UDI) requirements to integral Drug-Device Combinations (DDCs). Other sections were revised and clarify the impact of Article 117 on currently authorized integral DDCs and when a provision of the notified body opinion, the EU certificate or a declaration of conformity together with an Marketing Authorization Application (MAA) is required. The impact of MDR and article 117 on new MAAs is also clarified.
The updated and revised Q&A contains track changes making it easier to find the relevant information.