Guideline on the quality requirements for drug-device 6 combinations Draft

This guideline provides guidance on the documentation expected for Drug-Device Combinations (DDCs) in the quality part of the dossier for a marketing authorisation application or a variation application.

For the purpose of this guideline, medicinal products which contain one or more medical devices(s) as an integral part of the composition, as well as medicinal products for which one or more medical device(s) and/or device component(s) are necessary for use of the medicinal product are defined as DDCs. The types of DDCs within the scope of this guideline are medical device(s) and/or device component(s) that are integral to the medicinal product or non-integral (i.e. co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately).

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