Quality Requirements for Drug-Device Combinations EMA/CHMP/QWP/BWP/259165/2019 dated 29th May 2019: https://www.ema.europa.eu/en/quality-requirements-drug-device-combinations).
This outlines the dossier data requirements for drug-device combinations (DDCs). The consultation period for this draft runs until 31.08.2019.
This is an important draft guideline. 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.