Europe
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.
Source:
https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device