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AI Legal & ComplianceAugust 30, 2026

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.

Before market
Registration precedes placing on the market or putting into service — not after
Public by design
The database is built to be readable by the people the system affects
Two entries
A provider system entry, plus a separate one for public-authority deployers

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:

Conformity assessment
The procedure — internal control, or involvement of a notified body depending on the system — that establishes the requirements are met. Produces a conclusion, not a public record.
EU declaration of conformity
A document the provider draws up and keeps, in which it takes responsibility for compliance and identifies the system, the provider, and the requirements met.
CE marking
The visible mark affixed to the system or its documentation and packaging, indicating conformity. It travels with the product.
Database registration
The Annex VIII filing in the EU-level database, under the provider's name, before the system goes on the market. This is the only one of the four that a stranger can look up.

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.

1
Provider identity and contact details
Name, address, contact information — and, where the provider is established outside the Union, the identity of the authorised representative that files on its behalf.
2
Who is submitting, if not the provider
The name and details of the person submitting the information where that differs from the provider. Agencies and consultancies filing on a client's behalf need this straight.
3
The system's trade name and identifiers
The name the system is sold under plus any additional references allowing unambiguous identification — the field where a single platform sold under three product names causes an argument.
4
Intended purpose and description
A description of the intended purpose of the system, and of the components and functions it supports. This is the entry a competitor reads. It also has to match the technical file and the instructions for use.
5
Status and Member States
Whether the system is on the market, in service, or withdrawn, and the Member States in which it is or has been made available.
6
Conformity evidence references
A copy of, or reference to, the EU declaration of conformity, together with certificate details where a notified body was involved — including the body's identity.
7
The Annex III classification
Which high-risk area the system falls under, and — where relevant — the electronic instructions for use. Where a derogation is claimed, the registration reflects that claim rather than omitting the system.

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

Name one accountable owner
Not 'legal' or 'the compliance workstream'. A named person who holds the credentials, files the entry, and is responsible for updating status and Member State fields when they change.
Reconcile the product name across three documents
The registration, the declaration of conformity, and the instructions for use must identify the same thing. Marketing names and internal codenames diverge silently; catch it before the entry is public.
Confirm the authorised representative exists
Non-EU providers file through an authorised representative established in the Union, under a written mandate. If the mandate is unsigned, the filing has no valid submitter.
Decide the derogation question explicitly
Either the system is high-risk and registered as such, or it is in an Annex III area with a documented derogation and registered on that basis. 'We think it's fine' is not one of the two states.
Set a review trigger, not a review date
Tie re-verification of the entry to events that change it — a new Member State, a purpose change, a withdrawal, a notified-body certificate renewal — rather than to an annual calendar reminder that will miss all four.

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.

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