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European Economic Area (EEA) · Module Detail

European Economic Area: Standards & Conformity

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Commission standardisation request C(2025) 129 for machinery and related products (Valid from 2025-01-20): Request for new and revised harmonised standards supporting the Machinery Regulation.

6 instruments · 3 obligations · 9 claims · Next: (CEN and CENELEC target for availability of JTC 21 standards)

6 instruments (5 current) · 3 obligations · 9 claims · 6 milestones

Instruments

  • Commission standardisation request C(2025) 129 for machinery and related products Valid from 2025-01-20

    Request for new and revised harmonised standards supporting the Machinery Regulation.

    Conditionally binding · Verified · Official text
  • Commission standardisation request C(2025) 3871 for high-risk AI systems (M/613) Valid from 2025-06-23

    Revised request to CEN and Cenelec for harmonised standards supporting the AI Act, repealing the 2023 request; deadline 31 August 2025 with the decision expiring on 28 February 2027.

    Conditionally binding · Verified · Official text
  • Cyber Resilience Act Valid from 2024-12-10

    Cybersecurity requirements for products with digital elements; the AI Act treats compliance with the CRA's essential requirements as supporting Article 15 cybersecurity compliance for high-risk AI.

    Binding · Verified · Official text
  • EN 18286 Artificial Intelligence - Quality Management System for EU AI Act Regulatory Purposes Date not recorded

    CEN-CENELEC standard supporting Article 17 quality management; approved June 2026, Official Journal citation expected later in 2026.

    Non-binding · Verified · Official text
  • EN ISO/IEC 42001:2026 Artificial intelligence management system Valid from 2026-03-31

    European adoption of the AI management system standard ISO/IEC 42001 with no technical changes.

    Non-binding · Verified · Official text
  • Commission standardisation request C(2023) 3215 on artificial intelligence (M/593) Superseded Not current

    First AI standardisation request to CEN and CENELEC with a 30 April 2025 deadline, repealed and replaced in June 2025.

    Conditionally binding · Verified · Official text

Obligations

  • Article 1(1)

    CEN and Cenelec are requested to draft the harmonised standards and European standardisation deliverables listed in Annex I in support of the AI Act by 31 August 2025.

    other · Applies to: other · Commission standardisation request C(2025) 3871 for high-risk AI systems (M/613)
  • Article 3(1)

    CEN and Cenelec must report to the Commission every three months on progress in executing the request.

    other · Applies to: other · Commission standardisation request C(2025) 3871 for high-risk AI systems (M/613)
  • Article 1(1)

    CEN and CENELEC are requested to draft new harmonised standards and amend or revise existing ones in support of the Machinery Regulation by the Annex I deadlines.

    other · Applies to: other · Commission standardisation request C(2025) 129 for machinery and related products

Milestones

  • Deadline for CEN and Cenelec to draft AI Act harmonised standards under the request Moved
    Commission standardisation request C(2025) 3871 for high-risk AI systems (M/613)
  • Cyber Resilience Act Chapter IV (conformity assessment bodies) applies Met
    Cyber Resilience Act
  • Cyber Resilience Act Article 14 reporting of actively exploited vulnerabilities applies Met
    Cyber Resilience Act
  • (quarter)CEN and CENELEC target for availability of JTC 21 standards Upcoming
    Commission standardisation request C(2025) 3871 for high-risk AI systems (M/613)
  • Standardisation request C(2025) 3871 expires Upcoming
    Commission standardisation request C(2025) 3871 for high-risk AI systems (M/613)
  • Cyber Resilience Act applies generally Upcoming
    Cyber Resilience Act
Claims and evidence (9)
  • Derived: Probable EN 18286, approved by CEN-CENELEC in June 2026, is the first AI Act harmonised standard, covering the Article 17 quality management system; its Official Journal citation is pending.

    Confidence: Probable · As of 29 Jul 2026 · evidenced
    Evidence and sources
    • AI Act standardisation T1 · retrieved · retrieved 8 Oct 2026 · Standards18286: Artificial Intelligence - Quality Management System for EU AI Act Regulatory Purposes became the first harmonised standard for AI to enter public enquiry, allowing for national standardisation bodies to provide comments on the draft before its final publication.
    • CEN-CENELEC newsletter: ANEC contribution to EN 18286 T1 · retrieved · retrieved 8 Oct 2026 · Newsletter itemIn June, CEN and CENELEC approved EN 18286 'Artificial Intelligence: Quality Management System for EU AI Act Regulatory Purposes', the first European standard developed to support the implementation of the EU AI Act.
  • CEN and CENELEC approved EN 18286 in June 2026 and the Commission is expected to publish its reference in the Official Journal later in 2026, so no presumption of conformity yet follows.

    Confidence: Probable · evidenced
    Evidence and sources
    • CEN-CENELEC newsletter: ANEC contribution to EN 18286 T1 · retrieved · retrieved 8 Oct 2026 · Newsletter itemIn June, CEN and CENELEC approved EN 18286 'Artificial Intelligence: Quality Management System for EU AI Act Regulatory Purposes', the first European standard developed to support the implementation of the EU AI Act.
    • AI Act standardisation T1 · retrieved · retrieved 8 Oct 2026 · Standards18286: Artificial Intelligence - Quality Management System for EU AI Act Regulatory Purposes became the first harmonised standard for AI to enter public enquiry, allowing for national standardisation bodies to provide comments on the draft before its final publication.
  • BSI lists BS EN ISO/IEC 42001:2026 as the European and UK adoption of ISO/IEC 42001, published 31 March 2026.

    Confidence: Uncertain · As of 31 Mar 2026 · evidenced
    Evidence and sources
    • BS EN ISO/IEC 42001:2026 product page T3 · retrieved · retrieved 8 Oct 2026 · Product pageBS EN ISO/IEC 42001:2026 | 31 Mar 2026 | BSI Knowledge Standard # BS EN ISO/IEC 42001:2026 ## Information technology.
  • Commission Implementing Decision C(2025) 3871 of 23 June 2025 requests CEN and Cenelec to draft harmonised standards for high-risk AI systems under the AI Act, repeals Implementing Decision C(2023) 3215, and expires on 28 February 2027.

    Confidence: Confirmed · As of 23 Jun 2025 · evidenced
    Evidence and sources
  • CEN and Cenelec reported significant delays in AI Act standardisation work in their September 2024 joint semestrial report, prompting the Commission to set a new standards deadline of 31 August 2025.

    Confidence: Confirmed · As of 23 Jun 2025 · evidenced
    Evidence and sources
  • On 14-16 October 2025 the CEN and CENELEC Technical Boards adopted exceptional measures, including direct publication after a positive Enquiry vote, to make JTC 21 AI Act standards available by Q4 2026.

    Confidence: Probable · As of 23 Oct 2025 · evidenced
    Evidence and sources
  • Commission Implementing Decision C(2023) 3215, which set a 30 April 2025 AI standardisation deadline, was repealed by Implementing Decision C(2025) 3871 on 23 June 2025.

    Confidence: Confirmed · As of 23 Jun 2025 · evidenced
    Evidence and sources
  • Commission Implementing Decision C(2025) 129 of 20 January 2025 requests CEN and CENELEC to draft and revise harmonised standards supporting the Machinery Regulation (EU) 2023/1230, which covers machinery with AI-enabled self-evolving behaviour.

    Confidence: Confirmed · As of 20 Jan 2025 · evidenced
    Evidence and sources
  • CEN and CENELEC approved EN 18286, the first European standard developed to support implementation of the AI Act, in June 2026.

    Confidence: Confirmed · As of 1 Jun 2026 · evidenced
    Evidence and sources
    • CEN-CENELEC newsletter: ANEC contribution to EN 18286 T1 · retrieved · retrieved 8 Oct 2026 · Newsletter itemIn June, CEN and CENELEC approved EN 18286 'Artificial Intelligence: Quality Management System for EU AI Act Regulatory Purposes', the first European standard developed to support the implementation of the EU AI Act.