Quality documentation for medicinal products when used with a medical device - Scientific guideline

This guideline describes the information that should be presented in the quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device.

This guideline focuses on product-specific quality aspects of a medical device (integral, co-packaged or separately-obtained and referenced in the product information) that may have an impact on the quality, safety and efficacy of a medicinal product.

This guideline should be read in conjunction with the Q&A on the implementation of the Medical
Device Regulation.

Keywords: Medical device, medicinal products, Article 117, Notified Body opinion, Integral, Co-packaged, Referenced