Development of a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product - Scientific guideline

This concept paper addresses the need for development of a guideline on dossier requirements for medical devices that are supplied along with medicinal products where a device is necessary for administration or localisation (site-specific delivery) of the medicinal product.

Keywords: Drug-device combination products, drug-delivery medical devices, device verification and validation studies, quality management systems of medical devices

Current version

Concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product

Draft: consultation closed Consultation dates: 16/02/2017 to 16/05/2017 Reference Number: EMA/CHMP/QWP/BWP/661488/2016