Art.32

Article 32 — Presumption of Conformity with Requirements Relating to Notified Bodies

Governance SME Relevant ~2 min read · 451 words

Article 32 is a short but practically important article. It creates a presumption of compliance for conformity assessment bodies that meet the criteria set out in relevant harmonised standards. In plain terms: if a body is accredited to the right standards, it is presumed to meet the Article 31 requirements without needing to prove each criterion separately.

✓ Low compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

How harmonised standards simplify notified body qualification

Article 32 establishes a presumption of conformity mechanism for notified bodies. Where a conformity assessment body demonstrates compliance with harmonised standards published in the Official Journal of the European Union — specifically those covering the requirements of Article 31 — it is presumed to satisfy those requirements to the extent covered by the standards. This reduces the administrative burden of the qualification process.

WHAT IT SAYS

Accreditation to published standards equals presumed qualification

A conformity assessment body that meets the criteria in relevant harmonised standards published in the Official Journal is presumed to comply with the Article 31 requirements covered by those standards
This presumption is not absolute — it is rebuttable if evidence emerges that the body does not in practice meet the requirements
The relevant harmonised standards are those specifically published for this purpose under the AI Act — currently being developed through European standardisation bodies such as CEN-CENELEC
ISO 17021 and ISO 17065 are baseline accreditation standards already widely used by conformity assessment bodies that will form part of the harmonised standard framework
Where a harmonised standard does not yet exist for a particular aspect of Article 31, bodies must demonstrate compliance through documentary evidence reviewed by the notifying authority

WHO IS AFFECTED

Conformity assessment bodies and the notifying authorities assessing them

Conformity assessment bodies seeking to demonstrate Article 31 compliance efficiently through existing accreditation
National accreditation bodies that issue the accreditation certificates underpinning the presumption
Notifying authorities that rely on accreditation certificates to streamline their assessment process
Providers selecting notified bodies — accredited bodies benefit from the presumption and face less scrutiny during designation

WHAT IT MEANS FOR SMES

Look for accredited bodies — accreditation signals the presumption applies

This article directly affects which notified bodies you should prioritise: bodies with formal accreditation to relevant standards benefit from the presumption of conformity and have been through a rigorous independent verification process
When comparing notified bodies, an accredited body is generally a safer choice than one relying on documentary evidence alone — the accreditation provides a stronger and independently verified quality signal
As harmonised standards under the AI Act are still being finalised, check the Official Journal for updates — the list of standards underpinning the presumption will evolve over the coming years
For SMEs building AI systems: the existence of this presumption mechanism means the pool of qualified notified bodies should grow as more accredited bodies extend their scope to include AI Act assessments

Article 31 — Requirements for notified bodies (the requirements this presumption applies to)
Article 40 — Harmonised standards (the broader framework of standards under the Act)
Article 29 — Application procedure (where accreditation certificates are submitted)
Article 42 — Presumption of conformity for AI systems (the analogous mechanism for AI systems themselves)

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