Revision of ISO 10993-1: Why the 2025 update matters for MDR alignment
10/12/2025
The revised ISO 10993-1 standard was published in November 2025 and brings important changes to how biological safety for medical devices is evaluated. This article explains what defines ISO 10993-1, what the most significant changes to the biological evaluation of medical devices in the 2025 edition are, and why these updates matter for MDR certification.