This edition cancels and replaces the first edition (ISO 20417:2021), which has been technically revised.
ISO 20417:2026 sets out requirements for the information that manufacturers must supply with medical devices and their accessories, including labelling, packaging, and accompanying documentation. It aligns with EU MDR requirements and international best practices to support both patient safety and regulatory compliance.
🔽 Main Changes in ISO 20417:2026
– Update of normative references to reflect the latest standards and regulations
– Deletion of former informative Annexes D, F, G, and H
– Addition of the term ‘applicable policy’ to clarify compliance expectations
– Deletion of item b) in Clause 4 and item d) 1) in 6.1.2, streamlining the standard and clarifying manufacturer responsibilities
See the update here: https://lnkd.in/e92-Rmmz