Guideline on Quality Documentation for Medicinal Products When Used with a Medical Device

On 23 July 2021 the EMA published the guideline on product-specific quality aspects of a medical device.

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, or device part, and submitted in accordance with Directive 2001/83/EC and/or Regulation (EC) 726/2004. This 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.

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