On 10 November 2026, the Official Journal of the EU published two decisions on harmonised standards under the EU Medical Devices Regulations (MDR and IVDR). Commission Implementing Decision (EU) 2026/2479 amends harmonised standards under the EU MDR, while Commission Implementing Decision (EU) 2026/2481 amends one harmonised standard under the EU IVDR.
Harmonised standards translate EU legal requirements into common technical specifications. Once cited in the EU Official Journal, they provide a presumption of conformity, helping reduce trade barriers, facilitate market access, and ensure safety and interoperability.
New and revised harmonised standards under the EU MDR
Commission Implementing Decision (EU) 2026/2479 amends Implementing Decision (EU) 2021/1182 as regards harmonised standards for the following:
- Sterilisation of health care products
- Clinical investigation of medical devices for human subjects
- Natural rubber latex male condoms
- Biological evaluation of medical devices
- Washer-disinfectors
- Medical electrical equipment
- Small-bore connectors for liquids and gases in healthcare applications
The revision of those standards resulted in the adoption of harmonised standards EN ISO 11137-1:2026 and EN ISO 14155:2026:
The revision of further standards resulted in the adoption of the following new harmonised standards:
Revised harmonised standards under the EU IVDR: sterilisation of health care products
Commission Implementing Decision (EU) 2026/2481 amends Implementing Decision (EU) 2021/1195 as regards the harmonised standard for sterilisation of health care products under the EU IVDR.
The Commission made a request to CEN and CENELEC for the revision of existing harmonised standards on in vitro diagnostic medical devices developed in support of Directive 98/79/EC. The revision of that standard resulted in the adoption of the superseding harmonised standard EN ISO 11137-1:2026:
Contact MDlaw Team here for any questions on European standards, regulations, and compliance.
References:
Eur-Lex (2026). Commission Implementing Decision (EU) 2026/2479 of 9 November 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products, clinical investigation of medical devices for human subjects, natural rubber latex male condoms, biological evaluation of medical devices, washer-disinfectors, medical electrical equipment and small-bore connectors for liquids and gases in healthcare applications. Retrieved on 10 November 2026.
Eur-Lex (2026). Commission Implementing Decision (EU) 2026/2481 of 9 November 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for sterilization of health care products. Retrieved on 10 November 2026.
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