Art.71

Article 71 – EU Database for High-Risk AI Systems Listed in Annex III

High-Risk Systems SME Relevant ~3 min read · 503 words

Article 71 establishes the EU database for high-risk AI systems — the public register that providers must enter their systems into before market placement under Article 49. The database creates transparency about which high-risk AI systems are in use across the EU, enabling regulators, deployers, and the public to find information about the systems that affect their lives.

! High compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

The public register of high-risk AI systems

Article 71 establishes and defines the EU database — the central registry where providers of Annex III high-risk AI systems must register their systems before market placement. It sets out what information the database contains, who can access it, and how it is maintained. The database is managed by the Commission in collaboration with member states.

WHAT IT SAYS

Commission-managed, publicly accessible, with a non-public section for sensitive systems

The Commission establishes and maintains the EU database in collaboration with member states, setting its functional specifications in consultation with experts and the AI Board
Providers register information as specified in Annex VIII Sections A and B — covering system identity, provider details, intended purpose, compliance status, and the EU declaration of conformity
Public authority deployers register additional information in Section C of Annex VIII
The database is publicly accessible and machine-readable for most Annex III systems — anyone can look up registered AI systems
A non-public section exists for law enforcement, migration and asylum authority AI systems — accessible only to market surveillance authorities and the Commission
High-risk AI systems in the critical infrastructure category are registered at national level rather than in the EU database
The database also records real-world testing registrations under Article 60
The information in the database is kept up to date — providers must update their registration when relevant information changes

WHO IS AFFECTED

All providers of Annex III high-risk AI systems

Providers of Annex III high-risk AI systems — mandatory pre-market registration
Providers who self-assess their Annex III system as non-high-risk — also must register in a separate section
Public authority deployers of Annex III high-risk AI systems — must register their use
The European Commission maintaining the database
Market surveillance authorities and the public who access the database

WHAT IT MEANS FOR SMES

Your registration is a public record — get it right first time

The public accessibility of the database means your registration is visible to competitors, potential customers, regulators, journalists and civil society — treat it as a public-facing compliance declaration, not just a regulatory formality
The information in Annex VIII is specific and detailed — prepare it in advance as part of your technical documentation package rather than trying to complete it at the last minute before launch
The database is not yet fully operational as of the Act’s entry into force — monitor the AI Office’s announcements for when registration becomes available and what the process looks like in practice
Keeping your registration up to date is an ongoing obligation — build a review process into your product update procedures to ensure the database entry remains accurate
If you self-assess your system as non-high-risk under Article 6(3), you still have a registration obligation in a separate part of the database — this is commonly overlooked

Article 49 — Registration obligation (requires providers to register in this database)
Article 6 — High-risk classification (determines whether Annex III registration applies)
Annex VIII — Registration information (specifies exactly what must be entered)
Article 60 — Real world testing (testing registrations also go into this database)

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