News about GMP/cGMP


EMA: Updated and revised Q&A on MDR and IVDR

On 22 October 2019, the European Medicines Agency (EMA) released an revised and updated Q&A on the implementation of the EU Medical Devices Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR).

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.  

Source: Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) (With Track Changes)