Article 45: Information Obligations of Notified Bodies
Article 45 requires notified bodies to inform their notifying authority about: (a) any refusal, restriction, suspension, or withdrawal of certificates; (b) any circumstances affecting the scope or conditions of notification; (c) any request for information received from market surveillance authorities; (d) on request, conformity assessment activities performed and any other activities, including cross-border work. Notified bodies must also inform other notified bodies about refused or withdrawn certificates and (on request) about certificates issued.
Who does this apply to?
- -Notified bodies carrying out Annex VII conformity assessments
- -Notifying authorities supervising notified bodies
- -Market surveillance authorities receiving certificate status information
- -Providers whose certificate status is communicated to authorities
What notified bodies must report
Article 45 creates a transparency web among notified bodies, notifying authorities, and market surveillance:
1. Certificate decisions — refusals, restrictions, suspensions, withdrawals → notifying authority 2. Scope/conditions changes — anything affecting the notified body's designation → notifying authority 3. MSA information requests — any request for information from market surveillance → notifying authority 4. Activities reporting — on request: all conformity assessment activities, cross-border work, subcontracting → notifying authority 5. Peer notification — refused or withdrawn certificates → other notified bodies; issued certificates → on request
How Article 45 connects to the rest of the Act
- Article 44 — Certificate lifecycle that triggers Article 45 reporting.
- Article 43 — Conformity assessment procedures.
- Annex VII — Assessment procedure generating the certificates.
- Article 74 — Market surveillance authorities receiving information.
- Articles 28–42 — Notified body designation, notification, and operational requirements.
Compliance checklist
- Notified bodies: establish reporting procedures to notifying authority for all Article 45 events.
- Implement peer notification channels with other notified bodies.
- Providers: monitor whether your notified body's certificate decisions are communicated — affects your market placement rights.
- Authorities: integrate Article 45 reports into market surveillance workflows.
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Start Free AssessmentRelated Articles
Article 43: Conformity Assessment for High-Risk AI Systems
Article 44: Certificates Issued by Notified Bodies
Article 74: Market Surveillance and Control of AI Systems in the Union Market
Article 113: Entry into Force and Application Dates
Annex VII: Conformity Assessment Based on Assessment of Quality Management System and Technical Documentation
Related annexes
- Annex VII — Notified body conformity assessment
Frequently asked questions
Why does Article 45 matter to providers?
Certificate refusals or withdrawals are communicated to authorities and other notified bodies. A provider cannot quietly switch notified bodies after a refusal — the information follows.
Is this the same as NANDO reporting?
Article 45 is AI-Act-specific. NANDO is the Commission's database for notified bodies under EU product legislation. The two may interact but Article 45 creates distinct AI Act reporting duties.
What triggers a notified body's information-sharing duty under Article 45?
Article 45 requires notified bodies to inform their notifying authority and other notified bodies of refusals, restrictions, suspensions, or withdrawals of certificates. Upon request, they must also share positive certifications issued. The aim is to prevent 'forum shopping' and maintain consistent conformity assessment standards.