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Chapter IV — Notifying Authorities and Notified BodiesArticle 31

Article 31: Presumption of Conformity with Requirements Relating to Notified Bodies

Applies from 2 Aug 20265 min readEUR-Lex verified Apr 2026

Article 31 establishes a presumption of conformity: where a conformity assessment body demonstrates that it meets the criteria laid down in relevant harmonised standards (or parts thereof) whose references have been published in the Official Journal of the EU, it is presumed to comply with the requirements of Article 30 to the extent those standards cover those requirements. This provides the critical link between accreditation standards like EN ISO/IEC 17065 (product certification) and the AI Act's notified body requirements. Always verify on EUR-Lex.

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Who does this apply to?

  • -Conformity assessment bodies using harmonised standards to demonstrate compliance with Article 30 requirements
  • -Notifying authorities relying on accreditation certificates as evidence of Article 30 compliance
  • -Standardisation bodies (CEN, CENELEC, ETSI) developing harmonised standards referenced under Article 31

Scenarios

A conformity assessment body holds an EN ISO/IEC 17065 accreditation certificate with scope covering product certification for AI systems. The reference to EN ISO/IEC 17065 has been published in the Official Journal.

The body benefits from the presumption of conformity with Article 30 requirements covered by EN ISO/IEC 17065, such as independence, documented procedures, and impartiality. The notifying authority does not need to re-verify these elements. However, the body must separately demonstrate AI-specific competences not covered by the standard.
Ref. Art. 31 + Art. 30

No harmonised standard covering AI-specific fundamental rights competence has yet been published in the Official Journal.

The presumption of conformity does not apply for the fundamental rights expertise requirement. The conformity assessment body must provide direct evidence (e.g., staff CVs, training records, assessment methodology documentation) to satisfy the notifying authority that it meets this aspect of Article 30.
Ref. Art. 31 + Art. 30

What Article 31 does (plain terms)

Article 31 is a shortcut mechanism borrowed from the EU's New Legislative Framework (NLF). Instead of requiring every notifying authority to independently verify every Article 30 requirement from scratch, the article allows conformity assessment bodies to rely on harmonised standards as evidence.

The mechanism works as follows: 1. The European standardisation organisations (CEN, CENELEC, ETSI) develop harmonised standards for conformity assessment bodies operating under the AI Act. 2. The references to those standards are published in the Official Journal of the EU. 3. A conformity assessment body that demonstrates compliance with those standards (typically via accreditation) is presumed to meet the corresponding Article 30 requirements.

This presumption is rebuttable — the notifying authority can still require additional evidence if it has grounds to believe the standard does not fully cover a specific requirement. The presumption also only extends to the extent the standards actually cover the Article 30 requirements; any gaps must be filled with direct evidence.

Verify the full text on EUR-Lex Article 31.

The role of EN ISO/IEC 17065 and related standards

The primary harmonised standard expected to support the presumption of conformity is EN ISO/IEC 17065 (requirements for bodies certifying products, processes, and services). This standard covers core operational requirements like:

  • Impartiality and management of conflicts of interest
  • Competence of personnel
  • Documented evaluation processes
  • Records management and confidentiality
  • Internal audit and management review

However, EN ISO/IEC 17065 was not designed for AI-specific assessment. It does not cover AI-domain expertise (machine learning, data governance, fundamental rights) that Article 30 requires. Bodies will likely need to demonstrate these AI-specific competences through additional evidence or through future AI-specific harmonised standards developed under the AI Act standardisation request.

The status of harmonised standard references in the Official Journal should be monitored through the Articles 40–41 standardisation framework.

How Article 31 connects to the rest of the Act

  • Article 30 — The requirements for which the presumption of conformity can apply.
  • Article 40 — Harmonised standards for high-risk AI systems (general framework for standards under the AI Act).
  • Article 41 — Common specifications as a fallback when harmonised standards are absent or insufficient.
  • Article 29 — Application process, where the accreditation certificate supporting the presumption is submitted.
  • Article 113 — Application dates and staged entry into force.

Compliance checklist

  • Check the Official Journal for published references to harmonised standards applicable to AI Act notified bodies.
  • Obtain accreditation to EN ISO/IEC 17065 (or the relevant standard) with AI-related scope from the national accreditation body.
  • Map which Article 30 requirements are covered by your accreditation and which require separate evidence.
  • Prepare supplementary documentation for AI-specific competences (AI technology, data governance, fundamental rights) not covered by existing harmonised standards.
  • Monitor CEN/CENELEC work programmes for upcoming AI-specific harmonised standards that may expand the presumption of conformity.
Read the official text on EUR-Lex

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Frequently asked questions

Does the presumption of conformity mean a body automatically becomes a notified body if it holds accreditation?

No. The presumption simplifies the notifying authority's assessment but does not replace it. The body must still formally apply under Article 29, and the notifying authority must confirm that all Article 30 requirements are met — including any not covered by the harmonised standard.

What if no harmonised standard has been published for a specific Article 30 requirement?

The presumption of conformity does not apply for that requirement. The conformity assessment body must provide direct evidence to the notifying authority. The Commission may also adopt common specifications under Article 41 as a fallback.

Can the notifying authority override the presumption of conformity?

Yes. The presumption is rebuttable. If the notifying authority has specific grounds to believe the standard does not adequately cover a particular Article 30 requirement in the context of AI, it may require additional evidence.