EBE-EFPIA Position Paper: An Industry Perspective on Article 117 of the EU Medical Device Regulation: Clinical Requirements for Prefilled, Single-Use, Integral Drug-Device Combination Products
Prefilled, single-use, integral drug-device combinations (DDCs) are regulated as medicinal products. However, the device component needs to conform with “relevant” General Safety and Performance Requirements set out in Annex I of the Medical Device Regulation (MDR, Regulation (EU) 2017/745).
It is EBE and EFPIA’s views that for single-use, integral drug-device combination products, the clinical requirements for medicinal products take precedence over clinical evaluation requirements for medical devices. As a pragmatic approach, a Notified Body review of relevant device clinical information would be in the scope of the assessment by the Notified Body for the delivery of the Notified Body’s opinion.
Unless clarification is obtained now, there is a risk for conflicting and overlapping clinical requirements, with the coming into force of the MDR, as of 26 May 2020.
This paper considers these technical and procedural concerns and challenges being discussed amongst Industry, with a view that recommendations made are taken into consideration as guidance and implementing acts related to integral drug-device combination products get published.
Read here the position paper.