Impact of the MDR deferral on MAA of Drug Device Combination Products in Europe

In 2017 the Medical Device Regulation (regulation (EU) 2017/745) was released and supposed to replace the Medical Device Directive (directive 93/42/EEC) in May 2020. This was done to set new and higher requirements for Medical Devices (MD) market access, aiming at the improvement of the safety for patients.

For drug device combination products regulated as medicinal products according to MDR's article 1 (8), (9), an important change with MDR in comparison to MDD is the introduction of article 117 amending the Medicinal Product Directive 2001/83/EC.

In this article, your anteris medical team is happy to give you a summary of the main impacts.