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Chapter III, Section 5 — Standards, conformity assessment, certificates, registrationArticle 44

Article 44: Certificates Issued by Notified Bodies

Applies from 2 Aug 20264 min readEUR-Lex verified Apr 2026

Article 44 governs certificates issued by notified bodies after Annex VII conformity assessment. Certificates are valid for a maximum of 5 years and may be extended for further 5-year periods on application. Notified bodies must restrict, suspend, or withdraw certificates if the system no longer meets Chapter III requirements. The article also covers the obligation to inform the provider, other notified bodies, and national authorities about certificate decisions.

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Who does this apply to?

  • -Notified bodies issuing, extending, restricting, suspending, or withdrawing certificates
  • -Providers of high-risk AI systems that underwent Annex VII assessment
  • -Market surveillance authorities monitoring certificate status

Scenarios

A notified body issues a certificate for a biometric identification AI under Annex VII. The certificate is valid for 5 years.

The provider must apply for renewal before expiry or the certificate lapses. The notified body must conduct surveillance during the certificate period.
Ref. Art. 44

During periodic surveillance, a notified body discovers the provider's QMS has deteriorated significantly.

The notified body may restrict, suspend, or withdraw the certificate and must inform the provider with reasons. The provider loses the right to affix CE marking.
Ref. Art. 44

Certificate lifecycle (plain terms)

Issuance: Notified body issues a certificate after successful Annex VII assessment.

Validity: Maximum 5 years from issuance.

Extension: May be extended for further 5-year periods on application, provided the system continues to meet requirements.

Restriction / suspension / withdrawal: The notified body must act if the system no longer meets Chapter III, Section 2 requirements. The provider must be informed with reasons and given the opportunity to take corrective measures.

Information obligations: The notified body must inform its notifying authority, other notified bodies, and (where relevant) the Commission about certificate refusals, restrictions, suspensions, or withdrawals.

How Article 44 connects to the rest of the Act

  • Article 43 — Conformity assessment decision tree (when Annex VII and thus certificates are needed).
  • Annex VII — The assessment procedure that leads to certificate issuance.
  • Article 45 — Information obligations of notified bodies.
  • Article 47 — EU declaration references the certificate.
  • Article 48 — CE marking includes the notified body identification number.
  • Article 18 — Certificate must be kept for 10 years.
  • Annex VIII — Registration includes certificate details.

Compliance checklist

  • Track certificate validity dates and plan renewal applications well in advance.
  • Maintain ongoing compliance with Chapter III requirements during the certificate period.
  • Cooperate with notified body periodic surveillance.
  • If certificate is restricted or suspended: halt market placement until resolved.
  • Keep certificate copies for 10 years (Article 18).
  • Include certificate details in EU database registration (Annex VIII).
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Related annexes

  • Annex VII — Notified body conformity assessment
  • Annex VIII — Registration information

Frequently asked questions

Do all high-risk AI systems need a certificate?

No. Only systems assessed under Annex VII (notified body route) receive certificates. Systems assessed under Annex VI (internal control) do not — the provider self-declares.

What triggers certificate withdrawal?

Non-compliance with Chapter III, Section 2 requirements discovered during surveillance, or failure by the provider to take corrective measures within the required timeframe.

Can a certificate issued by a notified body be transferred or extended to a modified AI system?

Certificates cover the specific AI system configuration assessed. If a high-risk AI system undergoes substantial modification, a new or supplementary conformity assessment may be required under Article 43. The notified body may extend the certificate only if the modification does not affect the basis of the original assessment.