Quality documentation for medicinal products when used with a medical device - Scientific guideline
Table of contents
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
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Guideline on quality documentation for medicinal products when used with a medical device - First version (PDF/311.32 KB)
Adopted
First published: 23/07/2021
Legal effective date: 01/01/2022
EMA/CHMP/QWP/BWP/259165/2019 -
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Overview of comments received on 'Draft guideline on the quality requirements for drug-device combinations - First version' (PDF/2.94 MB)
First published: 08/12/2021
EMA/CHMP/QWP/BWP/725078/2021 -
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Draft guideline on the quality requirements for drug-device combinations - First version (PDF/302.99 KB)
Draft: consultation closed
First published: 03/06/2019
Consultation dates: 03/06/2019 to 31/08/2019
EMA/CHMP/QWP/BWP/259165/2019