MDCG 2024-2 Rev.1: Revolution in the European Medical Device Nomenclature

In January 2025, a significant milestone was reached in the medical devices sector with the publication of Revision 1 of the MDCG 2024-2. This document establishes dynamic procedures for updating the European Medical Device Nomenclature (EMN), reinforcing the commitment to modernization, safety and innovation in the sector.

Why is the EMR Update Important?

The annual updates, as well as the ad-hoc request processes, are not mere formalities. They represent a direct response to market needs and the rapid advance of technology. This continuous effort makes it possible:

• Innovation: Adapting quickly to new technologies and practices.

• Safety: Ensuring that devices are classified accurately, minimizing risks to patients.

• Trust: Strengthening credibility and transparency between manufacturers, healthcare professionals and patients.

The success of this regulatory model depends on active collaboration between all stakeholders. Feedback from professionals and users plays a crucial role in ensuring that the nomenclature remains relevant, effective and geared to future needs. This is a collective effort that reinforces regulatory excellence in the European Union.

MDCG 2024-2 Rev.1 is not just a technical document - it is a symbol of commitment to excellence, safety and innovation. It represents a revolution in the way medical devices are categorized, ensuring that technological advances are accompanied by effective regulatory practices.

For more details, download the full document.