Industry Analysis 9 min read

AI Act Harmonised Standards Delayed to Q4 2026: What This Means for Compliance

CEN-CENELEC's harmonised standards for the AI Act are running behind schedule. With the first standard (prEN 18286) closing its enquiry in January 2026 and publication pushed to Q4 2026, companies face a compliance gap. Here's what to do about it.

By Dr. Katharina Berger, Regulatory Affairs · Published

The Standards Gap

One of the EU AI Act's most important compliance mechanisms — harmonised standards — is running significantly behind schedule. The standards developed by CEN and CENELEC under Joint Technical Committee 21 (JTC 21) were originally expected to be ready well before the August 2, 2026 high-risk AI deadline. Instead, the first publications are now projected for Q4 2026, leaving companies in a difficult position.

This matters because harmonised standards provide a "presumption of conformity" — if your AI system meets the technical specifications in a harmonised standard, you are presumed to comply with the corresponding AI Act requirements. Without these standards, companies must demonstrate compliance through alternative means, which is more complex and less certain.

Current Status of Key Standards

prEN 18286 — Quality Management Systems (Article 17)

This is the most advanced standard in the pipeline. It covers QMS requirements for providers of high-risk AI systems. The enquiry period closed on January 22, 2026, and comments are now being resolved. Publication is expected in Q4 2026, meaning it will arrive after the August compliance deadline.

prEN ISO/IEC 24970 — Risk Management

Covering the critical risk management requirements of Article 9, this standard has reached consensus in the drafting group. A formal ballot is pending, with publication also expected in late 2026.

Conformity Assessment Framework

The standard supporting Article 43 conformity assessment procedures is in draft stage, with an enquiry period expected in early-to-mid 2026. This is particularly important for companies that need third-party conformity assessment.

Additional Standards in Development

StandardScopeStatus
ISO/IEC 42102AI taxonomy and terminologyCommittee draft approved
ISO/IEC 42109Human-machine teamingCommittee draft ballot closed Feb 2026
ISO/IEC 12792:2025Transparency taxonomyPublished
Risk CatalogueStructured risk documentationWork beginning 2026

What Companies Should Do Now

1. Don't Wait for Standards

The absence of harmonised standards does NOT delay your compliance obligations. The August 2, 2026 deadline applies regardless. Companies must achieve compliance using the AI Act's requirements directly, supplemented by common specifications (the European Commission can adopt common specifications as a fallback under Article 41), existing international standards (ISO 42001, ISO 23894, and other relevant standards provide useful frameworks), and the AI Act text itself (Articles 9-15 contain detailed requirements that can be implemented directly).

2. Build on ISO 42001

ISO 42001 — the AI Management Systems standard published in December 2023 — provides the closest existing framework to what the harmonised standards will likely require. While ISO 42001 certification does not create a presumption of conformity under the AI Act, it covers many of the same governance, risk management, and documentation requirements.

3. Monitor Standard Drafts

While you cannot rely on draft standards for presumption of conformity, reviewing publicly available drafts provides valuable insight into the technical direction. Aligning your compliance approach with the drafts now will minimize rework when the final standards are published.

4. Document Your Approach

In the absence of harmonised standards, clearly document how and why you believe your AI system complies with each applicable requirement. This documentation will be critical if challenged by a market surveillance authority.

The Bigger Picture

The standards delay highlights a broader challenge in EU technology regulation: the gap between legislative ambition and implementation infrastructure. For companies, the practical implication is clear: compliance cannot wait for perfect guidance. Organizations that are best prepared for August 2026 are those that started their compliance programs early and built flexible governance frameworks.

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