Registering high-risk systems in the EU database (Article 49)
Article 49 of the AI Act requires providers and certain deployers to register high-risk systems in a public EU database before deployment. The registration makes visible which systems are on the market and is a condition for lawful use.
Short answer: Article 49 of the AI Act requires providers to register their high-risk systems in an EU-managed, partly public database before the system is placed on the market or put into service. For some applications a registration duty also applies to the deployer (for example, certain public authorities). The registration is a hard condition, not an administrative afterthought.
What the EU database does
The EU database (governed by Article 71) is a central register of high-risk systems on the European market. Part of the data is publicly accessible, so that citizens, researchers and supervisors can see which systems are deployed for what. The register makes the high-risk landscape transparent and auditable; it connects to the broader transparency goals in the AI Act timeline of obligations.
Who registers what
Responsibility lies mainly with the provider, but not exclusively:
- Providers register themselves and their high-risk system before placing it on the market or putting it into service.
- Deployers that are public authorities (or act on their behalf) register the use of the system in certain cases.
- For systems the provider considers not high-risk despite falling within a high-risk category, a separate registration of that assessment applies.
The data to be supplied is set out in Annex VIII of the regulation: identity, description of the system, intended purpose and status.
When and how
Registration happens before deployment. Only then may the system lawfully be on the market or in use. The database is managed at EU level; the provider enters the data itself and keeps it current. If the system changes substantially, the registration must be updated โ just like the technical documentation and the post-market monitoring.
Relation to CE marking
Registration is a separate step alongside the conformity assessment and CE marking. Conformity demonstrates that the system complies; registration makes public that it exists. Both are conditions for lawful placing on the market. See the high-risk obligations overview for the connections.
What to do
- Determine your role: provider, public-authority deployer, or both.
- Gather the Annex VIII data in good time and in full.
- Register before deployment, not after โ it is a condition.
- Keep the registration current when the system changes substantially.
- Align with conformity: registration and CE marking go together.
An unregistered high-risk system, however well built, may not lawfully be on the market.
Sources
- https://eur-lex.europa.eu/eli/reg/2024/1689/oj
Regulation (EU) 2024/1689 (AI Act), Article 49 and Article 71: registration of high-risk systems in the EU database. - https://artificialintelligenceact.eu/article/49/
Article 49 AI Act: obligation to register in the EU database before placing on the market or putting into service.
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