Extended Regulation of Combination Products According to Article 117 EU MDR

The new EU Medical Device Regulation 2017/745 (EU MDR) not only brings new requirements for medical devices, but also for combination products - medicinal product/active substance plus medical device.

Two types of combination products in particular, characterized by the fact that they form an inseparable unit, are in focus:

  • integral combination products in which the drug performs the main function 
  • integral combination products where the medical device is used to administer the drug. Here, the combination product must be intended to be used exclusively in this drug/medical device combination and must not be reusable.

For these combination products the Directive 2001/83/EC "Medicinal Products for human use" applies, which will be extended by Article 117 MDR with an effective date of May 26, 2021. Among other things, this change has implications for the approval process.

This German language article by Maren Wiese, Senior Consultant Medical Devices, gempex GmbH, explains what these are and what else needs to be considered.

Augen auf bei den Kombinationsprodukten 
Regulatory Affairs - MDR - DeviceMed, 28.04.2021

The following aspects are considered:
- Additional control in the approval process for certain integral combination products
- Procedure for medical devices with CE marking
- Procedure for medical devices approved as a unit with the medicinal product
- Additional control in the life cycle of the combination product - substantial and non-substantial changes.

The article is initially provided on the website of the community portal:

For questions on the topic, Maren Wiese, author of the technical paper, is available via contact@gempex.com.