Art.41
EU AI Act Guide › Chapter III — High-Risk AI Systems › Article 41

Article 41 — Common Specifications

High-Risk Systems SME Relevant ~2 min read · 492 words

Article 41 provides a fallback compliance pathway when harmonised standards are not yet available. Where European standardisation organisations have not produced a harmonised standard covering a particular AI Act requirement, the Commission can step in and issue common specifications directly — giving providers a clear technical benchmark to comply with.

⚠ Medium compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

The Commission’s direct technical standards when harmonised standards are absent

Article 41 establishes the mechanism for common specifications — technically detailed requirements issued directly by the European Commission through implementing acts. They serve as the fallback compliance pathway when harmonised standards under Article 40 do not exist or are insufficient, ensuring providers are never left without a clear technical benchmark to comply with.

WHAT IT SAYS

Commission can issue common specifications in four circumstances

  • The Commission may adopt implementing acts establishing common specifications for the requirements set out in Section 2 where: no harmonised standard exists, harmonised standards are not sufficient to meet the Act’s requirements, a standardisation request has not been accepted, or published harmonised standards create inconsistencies with the Act
  • Common specifications must be developed with the involvement of relevant stakeholders — including national standardisation bodies, industry, and civil society
  • Providers who apply common specifications are presumed to comply with the requirements those specifications cover — the same presumption as for harmonised standards
  • Providers are not obliged to use common specifications — they may demonstrate compliance by alternative means, but doing so requires demonstrating equivalent compliance to the notified body or relevant authority
  • Where harmonised standards are subsequently published covering the same requirements, the common specifications cease to apply to the extent they are superseded
  • Common specifications also apply to general-purpose AI models where relevant obligations are covered

WHO IS AFFECTED

Providers building high-risk AI in areas lacking harmonised standards

  • Providers of high-risk AI systems operating in technical areas where harmonised standards have not yet been published
  • General-purpose AI model providers where common specifications cover GPAI obligations
  • Notified bodies that use common specifications as the technical benchmark for assessments
  • The Commission which develops and adopts the implementing acts
  • European standardisation organisations whose work may be supplemented or superseded by common specifications

WHAT IT MEANS FOR SMES

A bridge until harmonised standards arrive — use them when published

  • Common specifications are particularly relevant in the early years of the Act when harmonised standards are still being developed — they provide certainty when the standardisation process is incomplete
  • If no harmonised standard covers your specific AI system type when you need to demonstrate compliance, check whether the Commission has issued common specifications for that area
  • Common specifications have the same legal weight as harmonised standards for compliance purposes — compliance with them creates the same presumption of conformity
  • Monitor the Official Journal regularly — both harmonised standards and common specifications are published there and their publication dates determine when they become available as compliance pathways
  • If you develop your own compliance approach rather than using common specifications, document your reasoning thoroughly — you will need to demonstrate equivalent compliance during any conformity assessment

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← Previous Art. 40 — Harmonised Standards and Standardisation Deliverables Next → Art. 42 — Presumption of Conformity with Certain Requirements