EMA publishes draft guideline on quality requirements for DDCs

The latest document focuses on combinations of medicinal products and medical devices

The European Medicines Agency has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called drug-device combinations or DDCs).

Reporting on the news, the ECA Academy explained: "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."

What are DDCs?

More and more products coming on the market are so-called drug-device combinations. For this reason, EMA published a Question and Answer (Q&A) document at the end of February providing information on the implementation of the Medical Devices Regulation (2017/745; MDR).

The EMA's guideline on the quality requirements for drug-device combinations 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 such as enclosed spoons). Besides, two annexes as sample certificates for Notified Bodies supplement the draft," reports the ECA Academy.

The draft document is available on the EMA website.

Companies