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