Get a concise overview of the EU Medical Device Regulation (MDR), including the latest Amendment M5. Our MDR booklet helps manufacturers, quality managers, and other stakeholders efficiently understand and implement regulatory requirements.

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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.