There has been significant ongoing effort to clarify the regulatory requirements stemming from the EU Medical Device Regulation (MDR) for drug/device combinations (DDCs) and to ensure uniformity of rules for single, integral DDCs, but companies with these products are still uncertain as the MDR deadline of 26 May 2020 approaches. There is still a lack of essential structures and documents. Medtech Insight shares the exact words of industry leaders, the expected timeline of submission to a notified body and actual sharing of their opinions, and how Europe may not currently be at the forefront of healthcare regulation.