Update on Harmonized Standards
16.09.2025
Harmonized standards play a crucial role in simplifying the access to the Single European Market. More specifically, by following a harmonized standard, a manufacturer benefits from a presumption of conformity with the applicable regulation. For a standard to be harmonized, it must be cited in the Official Journal of the European Union. Harmonized standards are developed under the standing principle of consensus, originating both from international and European publications.
For the operation of the BEC committees, harmonized standards for the following regulations are being monitored:
- New Legislative Framework (765/2008, 768/2008, 2019/1020)
- General Product Safety Regulation (2023/988)
- Ecodesign Directive (2009/125/EC) and Ecodesign for Sustainable Products Regulation (2024/1781)
- Electromagnetic Compatibility Directive (2014/30/EU)
- Equipment for Explosive Atmospheres (2014/34/EU)
- Low Voltage Directive (2014/35/EU)
- Radio Equipment Directive (2014/53/EU)
- Restriction of Hazardous Substances (2011/65/EU)
- Medical Devices Regulation (2017/745) and In-Vitro Medical Devices Regulation (2017/746)
- Machinery Directive (2006/42/EC) and Machinery Regulation (2023/1230)
A full overview of European Directives and Regulations under the New Legislative Framework can be consulted on the dedicated page for Harmonized Standards, on the portal of the Single European Market. Changes to harmonized standards is an important topic for the proper functioning of BEC Technical Committees (TCs). As such, here under is a list of important decisions taken, for the period January-August 2025:
- New Legislative Framework (765/2008, 768/2008, 2019/1020)
- No changes to report.
- General Product Safety Regulation (2023/988)
- No changes to report.
- Ecodesign Directive (2009/125/EC) and Ecodesign for Sustainable Products Regulation (2024/1781)
- Commission Implementing Decision (EU) 2025/533 of 25 March 2025 on harmonized standards for refrigerating appliances with a direct sales function, drafted in support of Delegated Regulation (EU) 2019/2018 and Regulation (EU) 2019/2024.
- Amendment of 15 January 2025 to Implementing Decision (EU) 2021/936 of 3 June 2021 on harmonized standards for household washing machines and household washer-dryers drafted in support of Regulation (EU) 2019/2023 and Delegated Regulation (EU) 2019/2024.
- Electromagnetic Compatibility Directive (2014/30/EU)
- No changes to report, though it is worth noting that the European Commission has asked EMC committees to withdraw any cited standards that have been superseded by newer standards. As the citation of EMC standards has been tedious in the past few years, the amount of impacted standards is expected to be significant. Thus, the Coordination Group on EMC (CLC/COG EMC) is actively working to reduce the impact of this exercise.
- Equipment for Explosive Atmospheres (2014/34/EU)
- Amendment of 28 March 2025 to Implementing Decision (EU) 2022/1668 on harmonized standards for equipment and protective systems intended for use in potentially explosive atmospheres drafted in support of Directive 2014/34/EU of the European Parliament and of the Council.
- Machinery Directive (2006/42/EC) and Machinery Regulation (2023/1230)
- Amendment of 13 August 2025 Implementing Decision (EU) 2023/1586 on harmonized standards for machinery drafted in support of Directive 2006/42/EC of the European Parliament and of the Council.
- Low Voltage Directive (2014/35/EU)
- Amendment of 16 July 2025 to Implementing Decision (EU) 2023/2723 on harmonized standards for electrical equipment drafted in support of Directive 2014/35/EU of the European Parliament and of the Council.
- Commission Implementing Decision (EU) 2025/1464 of 17 July 2025 on harmonized standard EN 60335-2-14:2006 on particular requirements for kitchen machines drafted in support of Directive 2014/35/EU of the European Parliament and the Council.
- Amendment of 22 July 2025 to Implementing Decision (EU) 2023/2723 on harmonized standards for electrical equipment drafted in support of Directive 2014/35/EU of the European Parliament and of the Council.
- Radio Equipment Directive (2014/53/EU)
- Amendment of 28 January 2025 to Implementing Decision (EU) 2022/2191 on harmonized standards for radio equipment drafted in support of Directive 2014/53/EU of the European Parliament and of the Council.
- Amendment of 14 May 2025 to Implementing Decision (EU) 2022/2191 on harmonized standards for radio equipment drafted in support of Directive 2014/53/EU of the European Parliament and of the Council.
- Amendment of 13 August 2025 to Implementing Decision (EU) 2022/2191 on harmonized standards for radio equipment drafted in support of Directive 2014/53/EU of the European Parliament and of the Council.
- Restriction of Hazardous Substances (2011/65/EU)
- No changes to report.
- Medical Devices Regulation (2017/745) and In-Vitro Medical Devices Regulation (2017/746)
- Amendment of 8 April 2025 to Implementing Decision (EU) 2021/1182 on harmonized standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council.
- Amendment of 8 April 2025 to Implementing Decision (EU) 2021/1195 on harmonized standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council.