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EMA – Creation of a new group dedicated to combination products: Combination Products Operational Group (COMBO)

The group aims to facilitate dialogue on regulatory challenges at the intersection of pharmaceutical and medical device frameworks.

Combination products are medicines used in combination with a medical device or products that have to apply certain requirements from both medicine and device regimen.

The work of the group focuses on:

  • medicines that form an integral product with a medical device
  • medicines that include a co-packaged medical device;
  • medicines in exclusive use with a medical device, including in vitro diagnostics, referenced in the product information and supplied separately;
  • companion diagnostics;
  • medical devices incorporating an ancillary medicinal substance;
  • medical devices composed of (a combination of) substances that are systematically absorbed. 

More information on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (11 décembre 2025). EMA – Creation of a new group dedicated to combination products: Combination Products Operational Group (COMBO). ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/15bux


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