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Draft guideline on the quality requirements for drug-device combinations (PDF/302.99 KB)

Draft: consultation open

First published: 03/06/2019
Consultation dates: 03/06/2019 to 31/08/2019

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.