Quality requirements for drug-device combinations
Table of contents
Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post-authorisation application). The types of DDCs within the scope of this guideline are medical devices that are integral to the medicinal product, co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately.
Keywords: Drug-device combination products, drug delivery, medical devices, integral, non-integral, Article 117
- Consultation on draft guideline on quality requirements for medical devices in combination products
- Medical devices
-
Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
which currently addresses Article 117 of the new Medical Device Regulation, is very relevant for this guideline.