The European Medicines Agency (EMA) has published a new guidance document, titled ‘Guideline on quality documentation for medicinal products when used with a medical device’, providing advice on the quality information that manufacturers of combination products should submit in marketing authorization applications (MAA) to the Agency.
The guideline also incorporates the recent revision of the EU’s Medical Devices Regulations (MDR) in requiring makers of these products to obtain the results of conformity testing of the device part from a notified body (NB), giving both general and specific considerations on how to comply with the amendment to Annex 1 to Directive 2001/83/EC, introduced by Article 117 of the MDR, that requires such testing.
The guideline focuses on product-specific quality aspects of a medical device that may have an impact on the quality, safety and 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 a Q&A document published in June 2021 on the implementation of the MDR.
The guideline covers three types of combination products:
The guideline is scheduled to take effect on 1 January 2022.