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Regulatory Update

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.

Published on:
June 25, 2026

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

EntryPrevious referenceUpdated or added referenceSubject area
1aEN ISO 10993-23:2021EN ISO 10993-23:2021/A1:2025Biological evaluation of medical devices, Part 23: tests for irritation
7aEN ISO 10993-12:2021EN ISO 10993-12:2021/A1:2025Biological evaluation of medical devices, Part 12: sample preparation and reference materials
12aEN ISO 15223-1:2021EN ISO 15223-1:2021/A1:2025Symbols to be used with medical device labels, labelling, and information to be supplied
14aEN IEC 60601-2-83:2020EN IEC 60601-2-83:2020/A11:2021 and EN IEC 60601-2-83:2020/A1:2025Home light therapy equipment
20aEN ISO 10993-17:2023EN ISO 10993-17:2023/A1:2025Toxicological risk assessment of medical device constituents
52N/AEN ISO 1135-4:2025Transfusion equipment for medical use, transfusion sets for single use, gravity feed
53N/AEN ISO 1135-5:2025Transfusion equipment for medical use, pressure infusion apparatus for single use
54N/AEN ISO 10993-1:2025Biological evaluation of medical devices, evaluation and testing within a risk management process
55EN ISO 10993-5:2009EN ISO 10993-5:2009/A11:2025Tests for in vitro cytotoxicity
56N/AEN ISO 12870:2025Ophthalmic optics, spectacle frames
57N/AEN ISO 14607:2025Non-active surgical implants, mammary implants
58N/AEN ISO 14889:2025Ophthalmic optics, spectacle lenses, fundamental requirements
59N/AEN ISO 15883-1:2025Washer-disinfectors, general requirements, terms, definitions, and tests
60N/AEN ISO 15883-2:2025Washer-disinfectors for surgical instruments, anaesthetic equipment, and related articles
61N/AEN ISO 15883-3:2025Washer-disinfectors for human waste containers
62N/AEN ISO 15883-7:2025Washer-disinfectors for non-invasive, non-critical thermolabile medical devices and healthcare equipment
63N/AEN ISO 22675:2025Prosthetics, testing of ankle-foot devices and foot units
64N/AEN ISO 23908:2025Sharps injury protection, requirements and test methods
65EN 60601-1:2006EN 60601-1:2006/A13:2024Medical 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.

Official Source

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