EU Harmonized Standards 2026 Update: Decision (EU) 2026/1231
The European Commission has published Implementing Decision (EU) 2026/1231, updating the list of harmonized standards across several medical device areas. Manufacturers should review technical documentation, declarations, test documentation, and internal standards registers against the revised list.
The European Commission has published Commission Implementing Decision (EU) 2026/1231, updating the list of harmonized standards for medical devices. The update revises and adds standards across biological evaluation, symbols, medical electrical equipment, transfusion equipment, ophthalmic optics, implants, washer-disinfectors, prosthetics, and sharps injury protection.
Manufacturers should review technical documentation, declarations, test documentation, and internal standards registers against the revised list.
Key updates in the June 2026 harmonized standards list
The decision revises several existing standards, including:
- EN ISO 10993-23:2021.
- EN ISO 10993-12:2021.
- EN ISO 15223-1:2021.
- EN IEC 60601-2-83:2020, including A11:2021.
- EN ISO 10993-17:2023.
The decision also adds standards covering:
- Transfusion equipment.
- Biological evaluation.
- Ophthalmic optics.
- Non-active surgical implants.
- Washer-disinfectors.
- Prosthetics.
- Sharps injury protection.
- Medical electrical equipment.
Revised and newly added harmonized standards
| Entry | Previous reference | Updated or added reference | Subject area |
|---|---|---|---|
| 1a | EN ISO 10993-23:2021 | EN ISO 10993-23:2021/A1:2025 | Biological evaluation of medical devices, Part 23: tests for irritation |
| 7a | EN ISO 10993-12:2021 | EN ISO 10993-12:2021/A1:2025 | Biological evaluation of medical devices, Part 12: sample preparation and reference materials |
| 12a | EN ISO 15223-1:2021 | EN ISO 15223-1:2021/A1:2025 | Symbols to be used with medical device labels, labelling, and information to be supplied |
| 14a | EN IEC 60601-2-83:2020 | EN IEC 60601-2-83:2020/A11:2021 and EN IEC 60601-2-83:2020/A1:2025 | Home light therapy equipment |
| 20a | EN ISO 10993-17:2023 | EN ISO 10993-17:2023/A1:2025 | Toxicological risk assessment of medical device constituents |
| 52 | N/A | EN ISO 1135-4:2025 | Transfusion equipment for medical use, transfusion sets for single use, gravity feed |
| 53 | N/A | EN ISO 1135-5:2025 | Transfusion equipment for medical use, pressure infusion apparatus for single use |
| 54 | N/A | EN ISO 10993-1:2025 | Biological evaluation of medical devices, evaluation and testing within a risk management process |
| 55 | EN ISO 10993-5:2009 | EN ISO 10993-5:2009/A11:2025 | Tests for in vitro cytotoxicity |
| 56 | N/A | EN ISO 12870:2025 | Ophthalmic optics, spectacle frames |
| 57 | N/A | EN ISO 14607:2025 | Non-active surgical implants, mammary implants |
| 58 | N/A | EN ISO 14889:2025 | Ophthalmic optics, spectacle lenses, fundamental requirements |
| 59 | N/A | EN ISO 15883-1:2025 | Washer-disinfectors, general requirements, terms, definitions, and tests |
| 60 | N/A | EN ISO 15883-2:2025 | Washer-disinfectors for surgical instruments, anaesthetic equipment, and related articles |
| 61 | N/A | EN ISO 15883-3:2025 | Washer-disinfectors for human waste containers |
| 62 | N/A | EN ISO 15883-7:2025 | Washer-disinfectors for non-invasive, non-critical thermolabile medical devices and healthcare equipment |
| 63 | N/A | EN ISO 22675:2025 | Prosthetics, testing of ankle-foot devices and foot units |
| 64 | N/A | EN ISO 23908:2025 | Sharps injury protection, requirements and test methods |
| 65 | EN 60601-1:2006 | EN 60601-1:2006/A13:2024 | Medical electrical equipment, general requirements for basic safety and essential performance |
Action steps for medical device manufacturers
Manufacturers should:
- Identify affected products and product families.
- Review technical documentation against the updated standard references.
- Check declarations of conformity and internal standards registers.
- Confirm whether test reports and biological evaluation documentation remain current.
- Update labelling, symbols, and artwork controls where EN ISO 15223-1:2021/A1:2025 applies.
- Coordinate gap assessments with quality, regulatory, engineering, and EU market access teams.
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