Your CE Mark Is Not Your Registration
Most EU AI Act programmes are organised around proving the system conforms: risk management, technical documentation, conformity assessment, CE marking. All of that can be finished and filed while the one obligation that makes your system visible to a regulator — the Annex VIII entry in the EU database — still has no owner. It is the cheapest requirement in the Act and the easiest one for an authority to check.
Four Obligations That Get Collapsed Into One
Ask a compliance owner whether their high-risk system is "done" and you will usually get an answer about the technical file. The Act actually asks for four distinct things, produced by different people, at different moments:
The failure mode is not disagreement about these. It is that a programme plan lists "conformity" as a workstream, the workstream closes when the assessment concludes, and nobody notices that the fourth item was inside the same box. If you are still deciding whether your system is in scope at all, start with the high-risk classification guide first — registration only bites once classification lands.
What Annex VIII Actually Asks For
The information set is short. That is what makes it deceptive: it looks like a form, so it gets handed to whoever has database access, when several fields are positions the company has to decide and then live with in public.
Read items 3, 4 and 5 together and the operational problem appears. A registration is per-system, describes a fixed intended purpose, and states where the system is available. A SaaS product with a rolling roadmap, regional rollouts, and marketing that renames features every two quarters will drift out of alignment with its own entry within months. Registration is not a launch task that closes; it is a record that has to be kept true.
The Derogation Is a Filing, Not a Silence
A system listed in an Annex III area can still be treated as not high-risk where it does not pose a significant risk of harm to health, safety or fundamental rights — for instance because it performs a narrow procedural task, or merely improves the result of a previously completed human activity, without materially influencing the outcome of a decision. The exemption does not apply where the system profiles natural persons.
Providers relying on that route must document the assessment before placing the system on the market and register the system. In other words, the reward for concluding "not high-risk" is a public statement that you reached that conclusion — reviewable by an authority that can disagree. Companies that interpret the derogation as permission to disappear from the database have chosen the one version of the outcome that is both non-compliant and easy to detect. Our walkthrough of the derogation conditions covers how to write that assessment so it survives contact with a regulator.
Deployers: When You Get Your Own Entry
The deployer-side registration duty is narrow and specific: deployers that are public authorities, Union institutions, bodies, offices or agencies — or parties acting on their behalf — register themselves and identify the high-risk system they are using. That last clause is the one that catches private companies. A vendor operating a system on behalf of a public body can sit inside the obligation without ever having thought of itself as a registrant. If your contract base includes government customers, the question to ask before signing is not only "who is the provider" but "on whose behalf is this being deployed". The wider set of duties that follows is covered in the provider versus deployer breakdown.
A Registration Readiness Check
Frequently Asked Questions
When must registration happen?
Before the high-risk system is placed on the market or put into service. It is a precondition of availability, not a post-launch administrative task, which is why it needs to sit on the launch checklist next to the CE marking step rather than in a compliance backlog.
Does passing conformity assessment register the system?
No. Conformity assessment, the EU declaration of conformity, CE marking and database registration are four separate obligations. A notified body's involvement produces certificate details that go into the registration; it does not create the entry.
Who files when the provider is outside the EU?
The authorised representative established in the Union, appointed under a written mandate, registers on the provider's behalf and is identified in the entry. Without a valid mandate in place there is no one who can properly submit the filing.
Is the registration visible to the public?
The database is designed for public accessibility, with a restricted section for sensitive areas such as law enforcement, migration, asylum and border control. Assume commercial entries are readable by customers and competitors, and write the intended-purpose description accordingly — accurately, but knowing who reads it.
We claim the Annex III derogation. Do we register?
Yes. The provider documents the assessment before placing the system on the market and registers the system, so the derogation is on the record rather than inferred from your absence. The derogation is also unavailable where the system profiles natural persons.
Do private-sector deployers register?
Generally no — the deployer registration duty attaches to public authorities, Union institutions, bodies and agencies, and to parties acting on their behalf. Private deployers still carry the Article 26 duties: use per the instructions, assign competent human oversight, ensure input data relevance, and retain logs.
What is the penalty for not registering?
Non-registration is a breach of provider or deployer obligations and falls within the Act's penalty tiers, alongside market surveillance powers to require corrective action or restrict and withdraw the system. Because the omission is visible in a public database, it is unusually easy for an authority to establish.
Do the Cheap Half First
Registration is hours of work sitting behind months of work. If your classification is settled and your declaration of conformity exists, the entry is a same-week task — and it is the single item most likely to be checked by someone who has never seen your technical file.
If classification is not settled, that is the real project. Resolve it, then file, then set the change triggers that keep the entry honest.