What You Need to Know About the Current Status of EN 62368-1

For years, EN 62368-1 has been the staple to assess the safety of AVIT equipment for manufacturers and conformity assessment bodies alike. More specifically, manufacturers benefit greatly from the presumption of conformity it provides for all essential requirements of the Low Voltage Directive (2014/35/EU), as well as some of the requirements of the Radio Equipment Directive (2014/53/EU) and the General Product Safety Regulation (2023/988). In general, applying a harmonized standard to obtain a presumption of conformity drastically reduces the legal burden, as no additional verification by authorities or third-party assessors is needed. Granted, where it can be proven that the presumption of conformity is either incomplete or erroneous, a harmonized standard can be subjected to a formal objection, which typically leads to a citation in the Official Journal of the European Union (OJEU) with certain restrictions. Thus, harmonized standards need not provide a presumption of conformity for all essential requirements of a specific legislative act.

For conformity assessment bodies, the broad scope of EN 62368-1 makes it a versatile standard to use for a plethora of product categories. As mentioned previously, with the coverage of all AVIT equipment with a rated voltage up to 600 V, test laboratories across the world use this standard for common type tests, especially where product-specific safety standards do not exist or do not have an equivalent market acceptance, and where the product does not present risks requiring more extensive testing. In another sense, this standard serves as an important benchmark for other safety standards to align with, leading to countless normative references across a vast range of standardization domains.

Given the legal weight of harmonized standards for the European Market, the European Commission (EC) makes use of a so-called HAS-assessment to evaluate the alignment of a candidate harmonized standard with the essential requirements of the regulation(s) it is seeking to provide a presumption of conformity for. Only when the assessment comes back positive can the standard be cited in the OJEU to provide a presumption of conformity. However, in recent past, and mainly in the wake of the James Elliot Case (C-613/14) and the Malamud Case (C-588/21 P), the EC has become considerably stricter in its assessment of candidate harmonized standards. More specifically, as both cast doubt on the legal weight of harmonized standards, with the Malamud Case even going a step further by having the EC be summoned as a defendant in front of the European Court of Justice, the EC wishes to avoid such cases in the future at all costs.

For EN 62368-1, this has come with rather serious consequences, as the currently-cited version in the OJEU dates from 2014. While IEC 62368-1 continues to be revised and maintained on international level within IEC Technical Committee (TC) 108, the corresponding European adoptions systematically fall short during their HAS-assessment. Furthermore, where the outcome of an assessment can entail varying degrees of acceptance or lack thereof, the EC has consistently asked for newer versions of EN (IEC) 62368-1 to be fully rewritten in order to stand a chance of citation. This leads to another issue, where CENELEC TC 108X proceeded with the withdrawal of EN 62368-1:2014 on the 7th of January 2026 due to this standard being superseded twice, once by EN IEC 62368-1:2020 and again by EN IEC 62368-1:2024. Thus, the OJEU currently refers to a European standard that is, in principle, two generations old and no longer representative of the state of the art. This, coupled with the intention of the EC to “clean up the OJEU” by removing any references to withdrawn European standards, creates a very probable scenario in which no version of the EN 62368-1 is cited in the OJEU in the foreseeable future. Lastly, for the time being, CENELEC TC 108X is experiencing immense difficulties in having EN IEC 62368-1:2024 be cited, where the next steps require for direct exchanges with the EC to find a common way forward.

In the meantime, the BEC strongly encourages its members to adapt accordingly, by readying the Technical Construction File (TCF) and EU Declaration of Conformity (EU DoC) of impacted products to indicate compliance by means of alternative, non-harmonized approaches that require further analysis by the appropriate national market surveillance authorities if subjected to random spot checks or targeted investigations. BEC deems the time frame for this to take effect to be between 24 and 36 months, factoring in for an 18-month transitional regime following the withdrawal of a standard from the OJEU. Lastly, the BEC invites members interested in partaking in the standardization endeavors pertaining to the citation of EN IEC 62368-1:2024, and the drafting of future deliverables under the EN IEC 62368-series in general, to reach out to the Central Office of the Belgian Electrotechnical Committee (centraloffice@ceb-bec.be), who can provide further support in facilitating the participation to CENELEC TC 108X, and WG 03 in particular for the citation of EN IEC 62368-1:2024.