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Guideline on Quality Documentation for Drug-Device Combination Products - EMA

The European Medicines Agency (EMA) on 22-July-2021 has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications (MAA).

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.

This guideline focuses on product-specific quality aspects of a medical device (integral, co-packaged or separately obtained and referenced in the product information) that may have an impact on the quality, safety, and efficacy of a medicinal product.

This guideline should be read in conjunction with the Q&A on the implementation of the Medical Device Regulation. It applies to the following medicinal product types: chemical, biological or radiopharmaceutical.

The following are out of the scope of this guideline:

a) Veterinary products.

b) In-vitro diagnostic devices, including companion diagnostics.

c) System and procedure packs regulated under Article 22 of the MDR.

d) General groups of devices where reference is directly made, or inferred, in the product information, (e.g. “using a syringe or “an infusion line”, etc…).

e) Products falling under the first sub-paragraph of MDR Article 1(8).

“Guideline on quality documentation for medicinal products when used with a medical device” will be effective from 1/01/2022.


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