News about GMP/cGMP


EMA: Guideline on quality documentation for combination products

EMA: Guideline on quality documentation for combination products

Following a two-years drafting process the CHMP of the EMA has adopted the final guideline on quality documentation for medicinal products when used with a medical device on July 22, 2021.

The focus of the 22-page document is on product-specific quality aspects of a medical device and/or part of a medical device that may have an impact on the quality, safety or efficacy of a medicinal product, whether of chemical, biological or radiopharmaceutical type.  It is applicable for:

  • MPs where the medical device and/or device part and the medicinal product form an integral product that is not reusable (integral) and where the action of the medicinal product is principal
  • MPs placed on the market by the MAH, where the medical device is packed together with the medicinal product (co-packaged)
  • MPs where the product information refers to a specific medical device to be used with the medicinal product, and the medical device is obtained separately by the user of the medicinal product (referenced)

Not covered are

  • Veterinary products
  • In vitro diagnostic devices (including companion diagnostics)
  • System and procedure packs (MDR Article 22)
  • Devices where reference is directly made, or inferred, in the product information
  • Products falling under the first sub-paragraph of MDR Article 1(8).

The guideline adopted on July 22, 2021, will become effective on January 1, 2022.


EMA: Guideline on combination products