Art.49

Article 49 — Registration

High-Risk Systems SME Relevant ~2 min read · 490 words

Article 49 requires providers of high-risk AI systems to register themselves and their systems in the EU database before market placement. Registration creates a public record of high-risk AI systems in use across the EU — enabling regulators, deployers and the public to access key information about systems that affect people’s rights, safety and livelihoods.

! High compliance impact for SMEs

WHAT THE ARTICLE IS ABOUT

The EU’s public database of high-risk AI systems

Article 49 establishes the registration obligation — the requirement that providers of high-risk AI systems enter their details into the EU database maintained under Article 71 before placing their systems on the market. It is the Act’s transparency and traceability mechanism, creating a publicly accessible record that supports market surveillance and public accountability.

WHAT IT SAYS

Mandatory pre-market registration with important exceptions for sensitive systems

Before placing a high-risk AI system listed in Annex III on the market, the provider or authorised representative must register themselves and their system in the EU database — with the exception of systems in point 2 of Annex III (critical infrastructure)
Providers who have concluded their system is not high-risk under Article 6(3) must also register — in a separate section of the database indicating their self-assessment conclusion
Public authority deployers must also register themselves and their use of high-risk AI systems before deployment
High-risk AI systems used by law enforcement, migration, asylum and border control authorities must be registered in a secure, non-public section of the database — protecting sensitive operational information
High-risk AI systems covered by Annex I legislation in the area of critical infrastructure are registered at national level rather than in the EU database
The information required for registration is specified in Annex VIII — covering system identity, provider details, intended purpose, and compliance information

WHO IS AFFECTED

Providers of high-risk AI systems and public authority deployers

All providers of Annex III high-risk AI systems — mandatory pre-market registration
Providers who self-assess their system as non-high-risk under Article 6(3) — must still register in a separate section
Public authority deployers of Annex III high-risk AI systems — must register their use
Law enforcement, immigration, asylum and border authorities — register in the non-public section
Authorised representatives of non-EU providers who may complete registration on their behalf

WHAT IT MEANS FOR SMES

A mandatory pre-market step — budget time for it in your launch plan

Registration must happen before market placement — it is not something you do after launch, it is part of the launch process
The EU database is publicly accessible for most system types — your system’s registration will be visible to potential deployers, competitors, and the public; ensure the information you register is accurate
If you self-assess your system as non-high-risk under Article 6(3), you still have a registration obligation — this catches a common misconception that non-high-risk systems have no registration requirements
The registration process requires the information specified in Annex VIII — prepare this documentation in advance as part of your technical documentation package
As of the Act’s implementation, the EU database is being developed — monitor the AI Office’s communications for when registration becomes operationally available

Article 71 — EU database for high-risk AI systems (the database Article 49 requires registration in)
Article 16 — Provider obligations (registration is one of the twelve mandatory obligations)
Article 48 — CE marking (the other mandatory pre-market step alongside registration)
Annex VIII — Registration information (the specific data required for registration)

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