Quality requirements for drug-device combinations

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 


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