EMA published a guideline, effective from 1 January 2022, on quality documentation for medicinal products when used with a medical device (first version).

The guideline describes the information that should be presented in the Quality part of a MA dossier for a medicinal product when it is used with a medical device, or device part.

The guideline focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy (and hence overall benefit/risk determination) of a medicinal product.
The document should be read with EMA’s updated Q&A on the implementation of the Medical Device Regulation.


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