EU

EU AI Act: EU Database Registration Requirements

EU Database Registration Requirements [Art 49, 71, 80]

Rule: Providers and deployers of high-risk AI systems must register themselves and their systems in a publicly accessible EU database before placing on market or putting into service. Market surveillance authorities can reclassify systems initially deemed non-high-risk.

Effective: August 2, 2026 (high-risk systems registration)

Article 49: Registration Obligations

49.1 — Provider Registration (High-Risk AI Systems)

Who must register:

  • Providers (or authorized representatives) of high-risk AI systems listed in Annex III
  • Registration required before placing on market or putting into service

Exceptions: High-risk AI systems in Annex III, point 2 (critical infrastructure) are registered at national level instead of EU database.

Examples of Registration Requirement

System TypeMust Register in EU Database?
AI-powered hiring tool (Annex III point 4)✅ Yes — before market placement
AI for creditworthiness assessment (Annex III point 5)✅ Yes — before first use
Biometric identification system for law enforcement (Annex III point 1)✅ Yes — but in secure non-public section
AI for critical infrastructure management (Annex III point 2)❌ No — national-level registration only
Non-high-risk chatbot❌ No — unless provider claims non-high-risk under Art 6(3)

49.2 — Provider Registration (Self-Assessed Non-High-Risk)

Special requirement: Providers who determine their AI systems are not high-risk under Article 6(3) must still register themselves and their system.

Purpose: Creates audit trail for systems where provider made judgment call about risk classification.

Example:

A provider develops an AI system for employee task allocation. Under Annex III point 4, this could be high-risk (employment decisions). The provider assesses it as non-high-risk because it only suggests tasks, doesn’t make final decisions. Provider must register this determination.

49.3 — Deployer Registration (Public Authorities)

Who must register:

  • Public authorities or Union institutions/bodies
  • Deploying high-risk AI systems under their authority

What they register:

  1. Their identity and contact details
  2. The system they’re using (by selecting from provider’s registration)
  3. Summary of fundamental rights impact assessment (FRIA)
  4. Summary of data protection impact assessment (DPIA), if applicable

Timeline: Before putting into service

49.4 — Secure Non-Public Section

Special rules for sensitive sectors:

  • Law enforcement (Annex III point 1)
  • Migration, asylum, border control (Annex III points 6-7)

Differences:

  • Registration in secure non-public section of database
  • Access restricted to European Commission and relevant national authorities
  • Limited information fields (no instructions for use, no system description)

49.5 — National-Level Registration

Critical infrastructure systems (Annex III point 2) are registered at national level, not EU database.

Member States maintain separate registries for these systems.

Article 71: EU Database Structure

71.1 — Database Establishment

Administrator: European Commission, in collaboration with Member States

Purpose: Centralized registry of:

  • High-risk AI systems (Annex III)
  • Self-assessed non-high-risk systems (Article 6(3))
  • Real-world testing (Article 60)

71.2 — Information Content

Database contains information from Annex VIII:

SectionWho EntersWhat It Contains
Section AProvider/authorized repProvider details, system info, CE marking, declaration of conformity
Section BProvider/authorized repNon-high-risk classification justification
Section CDeployer (public authority)Deployer details, FRIA summary, DPIA summary

See Annex VIII details below for complete field lists.

71.3 — Public Access and Transparency

Publicly accessible information:

  • All information registered under Article 49 (except secure sections)
  • Must be in user-friendly manner
  • Easily navigable and machine-readable

Restricted access:

  • Real-world testing information (Article 60) — only market surveillance authorities and Commission
  • Law enforcement/migration/border control registrations (Article 49(4)) — only Commission and national authorities

Purpose: Enable consumers, deployers, market surveillance to:

  • Verify system compliance
  • Track recalls or safety issues
  • Make informed purchasing decisions
  • Conduct oversight

71.4 — Personal Data Minimization

Database contains minimal personal data:

  • Only names and contact details of representatives
  • Legally authorized to register systems
  • Must be necessary for registration purposes

GDPR compliance: Processing follows Regulation (EU) 2018/1725 (data protection in EU institutions).

71.5 — Commission Support

European Commission provides:

  • Technical infrastructure
  • Administrative support to users (providers, deployers, market surveillance)
  • Database maintenance and updates
  • Accessibility compliance (WCAG standards)

Article 80: Reclassification Procedure

80.1 — Market Surveillance Authority Powers

Trigger: Market surveillance authority has sufficient reason to believe a system classified by provider as non-high-risk is actually high-risk.

Process:

  1. Authority conducts evaluation under Article 6(3) standards
  2. Authority considers Commission guidelines on high-risk classification
  3. Authority assesses using objective criteria

80.2 — Required Actions if High-Risk

If evaluation confirms system is high-risk:

ActionTimelineResponsible Party
Directive to providerWithout undue delayMarket surveillance authority
Corrective actionsAuthority-specified deadlineProvider
Full complianceMust meet all Chapter III requirementsProvider
Union-wide correctionAcross all Member States where system placedProvider

Chapter III requirements include:

  • Risk management system (Article 9)
  • Data governance (Article 10)
  • Technical documentation (Article 11)
  • Conformity assessment (Article 43)
  • CE marking (Article 48)
  • Registration (Article 49)

80.3 — Cross-Border Notification

When system extends beyond one Member State:

  • Authority notifies European Commission without undue delay
  • Authority notifies other Member States without undue delay
  • Includes findings, required actions, and deadlines

Purpose: Coordinate enforcement across EU market.

80.4 — Provider Obligations

Once notified of reclassification:

  1. Compliance actions: Take all necessary steps to bring system into compliance
  2. Union-wide application: Ensure corrective measures apply to all systems in EU market
  3. Cease non-compliant use: Stop placing on market/putting into service until compliant

If provider fails to comply: Article 79(5)-(9) enforcement powers apply (withdrawal from market, recall).

80.5 — Penalties for Intentional Misclassification

Enhanced penalties apply when provider deliberately misclassified system to circumvent requirements.

Article 99 penalties:

  • Up to €15,000,000 OR 3% of total worldwide annual turnover (whichever higher)
  • For SMEs: Up to €3 million or 3% of total worldwide annual turnover (whichever higher)

Aggravating factors:

  • Intentional evasion of compliance obligations
  • Repeat violations
  • Refusal to cooperate with authorities

80.6 — Authority Use of Database

Information source: Market surveillance can use EU database information (Article 71) to:

  • Identify systems claimed as non-high-risk
  • Cross-reference provider declarations
  • Monitor compliance trends
  • Detect patterns of misclassification

Legal basis: Regulation (EU) 2019/1020 (market surveillance and product compliance).

Annex VIII: Registration Information Fields

Section A — Provider Registration (High-Risk Systems)

Required fields (Article 49(1)):

FieldDescription
1. Provider identityName, address, contact details
2. Submitter identityIf different person submitting on behalf of provider
3. Authorized representativeName, address, contact (if applicable)
4. System identificationTrade name and unique reference for traceability
5. Intended purposeDescription of purpose, components, functions supported
6. System descriptionBasic, concise description of data inputs and operating logic
7. StatusOn market / in service / no longer placed / recalled
8. Certificate detailsType and number of conformity assessment certificate (if applicable)
9. Certificate copyScanned copy of certificate (if applicable)
10. Geographic scopeMember States where system placed on market/put into service
11. Declaration of conformityCopy of EU declaration per Article 47
12. Instructions for useElectronic instructions (NOT required for law enforcement/migration/border systems)

Update requirement: Information must be kept current throughout system lifecycle.

Section B — Provider Registration (Non-High-Risk Systems)

Required fields (Article 49(2)):

FieldDescription
1. Provider identityName, address, contact details
2. Submitter identityIf different person submitting on behalf of provider
3. Authorized representativeName, address, contact (if applicable)
4. System identificationTrade name and unique reference for traceability
5. Intended purposeDescription of intended purpose
6. Classification justificationShort summary of grounds for non-high-risk classification under Article 6(3)
7. StatusOn market / in service / no longer placed / recalled
8. Geographic scopeMember States where system placed on market/put into service

Purpose of Section B: Creates transparency for provider self-assessments, enables market surveillance to identify potential misclassifications.

Section C — Deployer Registration (Public Authorities)

Required fields (Article 49(3)):

FieldDescription
1. Deployer identityName, address, contact details
2. Submitter identityPerson submitting on behalf of deployer
3. System referenceURL of system’s entry in EU database (links to provider registration)
4. FRIA summarySummary of fundamental rights impact assessment (Article 27)
5. DPIA summarySummary of data protection impact assessment per GDPR Article 35 or LED Article 27 (if applicable per Article 26(8))

When required: Before putting high-risk AI system into service.

FRIA requirement: All public authority deployers must conduct fundamental rights impact assessment before deployment (Article 27).

Registration Timeline

DateMilestone
August 2, 2026Registration obligations become mandatory for high-risk systems
August 2, 2027Full enforcement (providers must have completed registration)
Before market placementProvider registration deadline for new systems
Before putting into serviceDeployer registration deadline (public authorities)

Grace period for existing systems: Providers with systems already on market before August 2, 2026 have transition period (check Article 111 for specific dates).

Compliance Workflow

For Providers (High-Risk Systems)

  1. Risk classification: Determine if system is high-risk (Article 6, Annex III)
  2. Conformity assessment: Complete required assessment (Article 43)
  3. Technical documentation: Prepare per Article 11, Annex IV
  4. EU declaration of conformity: Draft per Article 47
  5. CE marking: Affix per Article 48
  6. Database registration: Register in EU database before market placement
    • Complete Section A of Annex VIII
    • Upload declaration of conformity
    • Provide instructions for use
  7. Update registration: Keep information current (status changes, recalls, etc.)

For Providers (Self-Assessed Non-High-Risk)

  1. Article 6(3) assessment: Document why system is not high-risk despite Annex III category
  2. Database registration: Register determination in EU database
    • Complete Section B of Annex VIII
    • Provide classification justification
  3. Maintain documentation: Keep assessment records for market surveillance audits
  4. Monitor for reclassification: Respond promptly if authority challenges assessment

For Deployers (Public Authorities)

  1. Verify provider registration: Check system in EU database
  2. Conduct FRIA: Fundamental rights impact assessment (Article 27)
  3. Conduct DPIA: If processing personal data (GDPR Article 35)
  4. Database registration: Register use in EU database before putting into service
    • Complete Section C of Annex VIII
    • Upload FRIA and DPIA summaries
  5. Monitor and log: Track system performance and incidents (Article 26)

Common Registration Pitfalls

MistakeConsequenceFix
Registering after market placementNon-compliance, potential fines up to €15M or 3% global revenueRegister BEFORE placing on market
Incomplete Annex VIII informationRegistration rejected or incompleteProvide all mandatory fields
No update when system recalledMisleads market, enforcement actionUpdate status immediately upon recall
Provider claims non-high-risk without documentationVulnerable to Article 80 reclassificationDocument Article 6(3) assessment thoroughly
Deployer skips FRIANon-compliance (Article 27 mandatory)Conduct FRIA before putting into service
Using wrong registration sectionConfusion, potential non-complianceHigh-risk → Section A; Non-high-risk → Section B; Deployer → Section C

Database Access and Queries

Public Can View:

  • Provider names and contact information
  • System names and intended purposes
  • High-level system descriptions
  • CE marking and conformity certificates
  • Geographic availability (which Member States)
  • System status (on market, recalled, etc.)

Public Cannot View:

  • Detailed operating logic or algorithms
  • Real-world testing data (unless provider consents)
  • Law enforcement/migration/border control system details
  • Proprietary technical specifications

Market Surveillance Authorities Can View:

  • Everything public can view, PLUS:
  • Real-world testing information (Article 60)
  • Secure non-public section (law enforcement/migration/border)
  • Full technical documentation (via inspection powers)

Machine-Readable Format

Requirement: Database must be machine-readable for automated compliance checking.

Use cases:

  • Automated procurement checks (public authorities verify compliance before purchase)
  • Supply chain verification (deployers check provider registration)
  • Consumer apps (scan CE marking, look up system in database)
  • Research and analysis (aggregated statistics on AI system types)

Format: Likely JSON or XML API, details to be specified in Commission implementing acts.

Penalties for Registration Violations

ViolationFine (Large Companies)Fine (SMEs)
Failure to register (high-risk)Up to €15M or 3% global revenueUp to €3M or 3% global revenue
Incomplete/false informationUp to €15M or 3% global revenueUp to €3M or 3% global revenue
Failing to update registrationUp to €7.5M or 1.5% global revenueUp to €1.5M or 1.5% global revenue
Intentional misclassification to evadeUp to €15M or 3% global revenue (aggravated)Up to €3M or 3% global revenue (aggravated)

Article 99 basis: Registration obligations fall under Article 49 (provider obligations) and Article 26 (deployer obligations).

Interaction with Other Requirements

CE Marking (Article 48)

  • Cannot affix CE marking without completing registration
  • CE marking indicates conformity + registration completion

Conformity Assessment (Article 43)

  • Registration includes uploading conformity assessment certificate
  • Certificate number must match database entry

Market Surveillance (Chapter IX)

  • Authorities use database to:
    • Identify systems for inspection
    • Track compliance trends
    • Coordinate cross-border enforcement

Fundamental Rights Assessment (Article 27)

  • Deployer FRIA summary uploaded to database (public authorities)
  • Creates transparency for civil society oversight

Compliance Checklist

Providers (High-Risk Systems)

  • Determine system is high-risk (Article 6, Annex III)
  • Complete conformity assessment (Article 43)
  • Prepare technical documentation (Article 11)
  • Draft EU declaration of conformity (Article 47)
  • Register in EU database before market placement (Article 49(1))
  • Complete all Section A fields of Annex VIII
  • Upload declaration of conformity and instructions for use
  • Affix CE marking (Article 48)
  • Update registration upon any changes (status, recall, modifications)

Providers (Self-Assessed Non-High-Risk)

  • Document Article 6(3) assessment (why not high-risk)
  • Register in EU database (Article 49(2))
  • Complete all Section B fields of Annex VIII
  • Provide clear classification justification
  • Maintain documentation for potential Article 80 challenges
  • Update registration upon any changes

Deployers (Public Authorities)

  • Verify system registered by provider in EU database
  • Conduct fundamental rights impact assessment (Article 27)
  • Conduct data protection impact assessment if applicable (GDPR Article 35)
  • Register in EU database before putting into service (Article 49(3))
  • Complete all Section C fields of Annex VIII
  • Upload FRIA and DPIA summaries
  • Implement human oversight (Article 14)
  • Monitor system performance (Article 26)

Citation

Article 49 — Registration, Regulation (EU) 2024/1689

Article 71 — EU Database for High-Risk AI Systems, Regulation (EU) 2024/1689

Article 80 — Procedure for Non-High-Risk Reclassification, Regulation (EU) 2024/1689

Related:

Contains public sector information licensed under the Open Government Licence v3.0 where applicable. This is not legal advice. Always refer to official sources for authoritative text.

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