El MDCG actualiza la guía sobre la clasificación de dispositivos médicos

On 20 April 2026, the Medical Device Coordination Group (MDCG) published Revision 1 of MDCG 2021-24 on the classification of medical devices under the MDR. The update introduces targeted revisions across multiple sections of the guidance, including updates to definitions, clarifications in the application of classification rules, and expanded practical examples supporting rule interpretation.

Key changes include refinements to general classification principles, updates to definitions (e.g. implantable devices and invasiveness), and revisions to several classification rules and corresponding tables — particularly Rules 2, 8, 9, 10, 12, 16, and 22. In addition, new notes and clarifications have been added to support the handling of practical classification challenges and borderline cases.

Overall, Rev. 1 strengthens the guidance by improving clarity, consistency, and usability, helping manufacturers and notified bodies apply the MDR classification rules in a more harmonised and predictable way.

What does this mean for you?

Manufacturers should review and, where needed, update their device classification justifications to ensure alignment with the revised MDCG guidance.

In particular, ensure that classifications are clearly justified, consistent with updated definitions and rules, and robust enough for notified body scrutiny.

This is especially relevant for borderline or complex cases, where the updated examples and notes may impact existing decisions.