In August 2025, the EU revised MDCG 2019‑11, the key guidance on how software is classified as a medical device under MDR Rule 11. For digital health and SaMD developers, this update can change risk class and impact the entire regulatory plan. Why this update matters MDCG 2019‑11 explains how Rule 11 of MDR Annex VIII applies to software and helps decide whether a product is class IIa, IIb, or III based on its intended purpose and clinical impact. The 2025 revision adds clear
