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 MedicalDevice Regulation.

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

Current version - effective from 1/01/2022

Guideline on quality documentation for medicinal products when used with a medical device - First version

Adopted Reference Number: EMA/CHMP/QWP/BWP/259165/2019 Legal effective date: 01/01/2022

Document history

Guideline on quality documentation for medicinal products when used with a medical device - First version

Adopted Reference Number: EMA/CHMP/QWP/BWP/259165/2019 Legal effective date: 01/01/2022

Overview of comments received on 'Draft guideline on the quality requirements for drug-device combinations - First version'

Reference Number: EMA/CHMP/QWP/BWP/725078/2021

Draft guideline on the quality requirements for drug-device combinations - First version

Draft: consultation closed Consultation dates: 03/06/2019 to 31/08/2019 Reference Number: EMA/CHMP/QWP/BWP/259165/2019