The European Medicines Agency (EMA) has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications. 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 of a medicinal product and outlines where this information should be placed in the Common Technical Document. The guideline should be read in conjunction with the Q&A on the implementation of the MDR.
July 27, 2021