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

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Concept paper

Reference numberEMA/CHMP/QWP/BWP/661488/2016
Published16/02/2017
KeywordsDrug-device combination products, drug-delivery medical devices, device verification and validation studies, quality management systems of
medical devices
DescriptionThis 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.

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