29/30 September 2021
The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs). What does the draft contain?
More and more products coming on the market are so-called Drug Device Combinations. For this reason, the EMA published a Question and Answer (Q&A) document at the end of February already. It provides information on the implementation of the Medical Devices Regulation (2017/745; MDR). Now, the EMA is following suit with a draft guideline entitled "Guideline on the quality requirements for drug device combinations". This draft guideline also deals with the implementation of the Medical Devices Regulation - and, in particular, with Article 117 of the MDR. The draft guideline describes which quality-relevant information is to be submitted in the context of the marketing authorisation. Furthermore, variations of the marketing authorisation within the framework of the life cycle are addressed.
The 26-page document is very extensive. The main part focuses on the contents of the individual marketing authorisation modules for integral DDCs (medical devices that are integral to the medicinal product) and non-integral DDCs (medical devices that are not integral to the medicinal product, for example enclosed spoons). Besides, two annexes as sample certificates for Notified Bodies supplement the draft.
The draft "Guideline on the quality requirements for drug-device combinations" is available on the EMA website and can be commented until the end of July.