EBE-EFPIA Position Paper: An Industry Perspective on Article 117 of the EU Medical Device Regulation: Labelling Requirements for Prefilled, Non-Reusable, Integral Drug-Delivery Device Combination Products
Prefilled, non-reusable, integral drug-device combinations (DDCs) are regulated as medicinal products, if the intention is to administer the medicinal product to the patient. 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 non-reusable, integral drug-device combination products, the labelling requirements for medicinal products take precedence over labelling requirements for medical devices. As a pragmatic approach, a Notified Body’s review of the “Instructions for Use” for the device component could be in the scope of the assessment by the Notified Body for the delivery of the Notified Body’s opinion. In addition, EBE and EFPIA recommend special considerations be given to complex innovative DDCs, use of international symbols and CMR (carcinogenic, mutagenic or toxic to reproduction) and endocrine-disrupting substances.
Unless clarification is obtained now, there is a risk for conflicting and overlapping labelling 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.