Art.34

Article 34 — Operational Obligations of Notified Bodies

Governance SME Relevant ~2 min read · 426 words

Article 34 sets out how notified bodies must conduct themselves when actually carrying out conformity assessments. Having been designated under Articles 28-30 and meeting the requirements of Article 31, notified bodies now face detailed obligations about how they perform their work — including proportionality, impartiality, and what to do when they find non-conformity.

✓ Low compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

How notified bodies must conduct their assessments

Article 34 governs the operational conduct of notified bodies when performing conformity assessments of high-risk AI systems. It moves from what a notified body must be (Articles 31–32) to what it must do — specifying procedural obligations, handling of findings, and the relationship with providers during the assessment process.

WHAT IT SAYS

Proportionate, documented, and responsive to non-conformity

Notified bodies must carry out conformity assessments in a proportionate manner — avoiding unnecessary burdens on providers, particularly SMEs, while ensuring technical rigour
They must conduct assessments in a transparent and non-discriminatory way, treating all providers fairly
Where a notified body finds non-conformity during an assessment, it must give the provider the opportunity to remedy the situation before refusing or restricting certification
Notified bodies must document all assessment activities, findings, and decisions in a way that enables reproducibility and traceability
They must have procedures for handling appeals and complaints from providers
Notified bodies must inform their notifying authority of any systemic issues they discover across multiple assessments that may indicate broader market compliance problems
They must participate in peer-review and coordination activities with other notified bodies to ensure consistent application of assessment standards

WHO IS AFFECTED

Notified bodies and the providers they assess

Notified bodies in their day-to-day assessment operations
Providers of high-risk AI systems submitting their systems for third-party conformity assessment
Notifying authorities who monitor whether their designated bodies are operating correctly
Other notified bodies participating in coordination activities

WHAT IT MEANS FOR SMES

Procedural protections you can rely on during assessment

The proportionality obligation is explicitly designed to protect SMEs — notified bodies cannot apply the same administrative burden to a small startup that they apply to a large corporation
The opportunity to remedy non-conformity before certification is refused is a significant protection — you are not automatically failed on first finding; you have a chance to fix identified issues
The appeals and complaints procedure means you have a formal route to challenge an assessment decision you believe was wrong
The documentation requirements work in your favour: if an assessment is later disputed, the notified body must be able to produce a complete record of what they did and found
Ask your notified body upfront about their SME-specific procedures — Article 34’s proportionality requirement means they should have them

Article 31 — Requirements for notified bodies (the standards underpinning operational conduct)
Article 43 — Conformity assessment (the specific procedure notified bodies follow)
Article 44 — Certificates (the output of a successful conformity assessment)
Article 37 — Challenge to competence (what happens if operational conduct is questioned)

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