Update on EN IEC 62368-1:2024 + A11:2024 and OJEU Harmonization Status

Earlier this year, CENELEC TC108X addressed the initial comments raised during the HAS consultant assessment and prepared a draft prA12 amendment intended to resolve the identified non-compliances. At that time, there was cautious optimism that the next HAS review would confirm alignment with EU legislative requirements and allow the new edition to progress toward publication as a harmonized standard in the OJEU.

However, the outcome of the October 2025 HAS assessment differed significantly from expectations. Three HAS consultants—covering the LVD, GPSR, and RED—issued approximately 500 comments, several of which call for substantial technical and structural revisions to the standard. After evaluating the scope and nature of these comments, TC108X decided to discontinue further engagement with the HAS consultants for this edition.

Consequently, it is now highly unlikely that EN IEC 62368-1:2024 + A11:2024 will be published as a harmonized standard in the OJEU.

The Date of Withdrawal (DoW) for EN IEC 62368-1:2020 + A11:2020 has not been extended, as EN 62368-1:2014 is scheduled to be removed from the CENELEC list of standards. Nevertheless, it will remain listed as a harmonized standard under the LVD until the European Commission formally decides to withdraw it. The timing of this removal is entirely dependent on the Commission and cannot currently be predicted.

Manufacturers and conformity assessment bodies should therefore plan for continued use of the existing harmonized version until further regulatory action is announced.

More information:
Boštjan Glavič
E-mail: bostjan.glavic@siq.si
Tel.: +386 1 4778 265