EMA Updated Questions & Answers on Implementation of MDR and IVDR (specifically in regard to Integral Drug-Device Combinations (DDCs))

The EMA has updated the answers to several questions related to integral drug-device combinations in the Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746). These updates provide clarity on regulatory requirements and procedures for marketing authorisation applications involving integral DDCs.

IMPACT: The updates in this Q&A document pertain to the Declaration of Conformity requirements for integral drug-device combinations.

Summary: The edits in the Q&A document reiterate MDR Article 52(7) compliance in issuing the EU declaration of conformity (DoC), when a DoC is not available for class I devices (excluding Class I devices that are sterile, have a measuring function, or are reusable). In such a case, for class I (excluding Is and Im) devices, the MAH may submit an MAH’s “statement of compliance” with the relevant General Safety and Performance Requirements (GSPRs) of MDR Annex 1. 

Sources: Link to the redlined Q&A document: Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)