New Harmonised Standards Under MDR and IVDR
On 11 June 2026, the European Commission published Implementing Decision (EU) 2026/1231 (MDR) and on 15 June 2026 Implementing Decision (EU) 2026/1313 (IVDR), introducing further updates to the lists of harmonised standards supporting the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
These updates continue the ongoing effort to ensure that harmonised standards remain aligned with the latest scientific and technical developments and support consistent implementation of the MDR and IVDR across the EU.
Key Updates Under the MDR
Implementing Decision (EU) 2026/1231 amends Decision (EU) 2021/1182, mainly through the replacement of existing entries and the addition of new standards.
Biological Evaluation (Major Updates and New References)
- EN ISO 10993-1:2025 — general principles for biological evaluation
- EN ISO 10993-23:2021/A1:2025 — irritation testing
- EN ISO 10993-12:2021/A1:2025 — sample preparation
- EN ISO 10993-17:2023/A1:2025 — toxicological\u200B risk assessment
- EN ISO 10993-5:2009/A11:2025 — cytotoxicity
Labelling and Symbols
- EN ISO 15223-1:2021/A1:2025 — symbols for information supplied by the manufacturer
Medical Electrical Equipment
- EN IEC 60601-2-83:2020 + amendments — home light therapy equipment
- EN 60601-1:2006/A13:2024 — general safety and essential performance
Transfusion and Infusion Systems
- EN ISO 1135-4:2025 — transfusion sets (gravity feed)
- EN ISO 1135-5:2025 — transfusion sets (pressure infusion)
Reprocessing and Infection Control Equipment
- EN ISO 15883 series (Parts 1, 2, 3, and 7:2024–2025) — washer-disinfectors
Implants and Specialty Devices
- EN ISO 14607:2025 — mammary implants
- EN ISO 22675:2025 — prosthetic ankle-foot devices
Ophthalmic Devices
- EN ISO 12870:2025 — spectacle frames
- EN ISO 14889:2025 — spectacle lenses
Safety Devices
- EN ISO 23908:2025 — sharps injury protection mechanisms
Key Updates Under the IVDR
Implementing Decision (EU) 2026/1313 amends Decision (EU) 2021/1195, with newly harmonised standards aligned with the MDR update:
Labelling and Symbols
- EN ISO 15223-1:2021/A1:2025 — symbols for information supplied by the manufacturer
Why These Updates Matter
These updates ensure that harmonised standards reflect the latest scientific and technical progress and remain aligned with MDR/IVDR requirements. By applying these standards, manufacturers can continue to benefit from the presumption of conformity with applicable General Safety and Performance Requirements (GSPRs), making them a key tool for demonstrating compliance.
Several previously harmonised standards are withdrawn or replaced, requiring manufacturers to assess transition timelines and update technical documentation accordingly.
What Does This Mean for You?
Manufacturers should review whether the new or updated harmonised standards apply to their devices and assess the impact on design, testing, clinical evaluation, and labelling.
Technical documentation and ongoing projects should be reviewed and updated where necessary to align with the latest harmonised standards, particularly where previous versions have been replaced or withdrawn.
How QbD Group Can Help
Our regulatory affairs experts support manufacturers in interpreting harmonised standards, gap-assessing technical documentation, and aligning quality systems with the latest MDR and IVDR requirements. Get in touch to ensure your devices stay compliant.