Declaration of Conformity, CE marking and Annex VIII registration

Three provider steps close out the pre-market journey for a high-risk system: draw up the declaration, affix the CE marking, and register in the EU database. They follow the Art. 43 conformity assessment — internal control under Annex VI for most Annex III systems, a notified body under Annex VII for certain biometric systems — and, for Annex III systems, they apply from 2 December 2027.

The Art. 47 declaration

The EU Declaration of Conformity is the provider's written, machine-readable, signed attestation — issued under its sole responsibility — that the system meets the requirements of Chapter III Section 2. It is drawn up per system, kept for ten years after market placement, and updated when anything changes. Annex V fixes its content.

In Veritome the declaration is a prescribed document: the field set, the order and the meaning are the Annex's, and every field cites the Annex V point it answers — system name and identification, provider name and address, the statement that the declaration is issued under the provider's sole responsibility, the statement of conformity, the harmonised standards or other common specifications applied, the notified body and its certificate where one was involved, and the place, date and signatory. The editor (open it from the system, or from Documents) pre-fills the system name and provider from the live record and the notified-body name and number from your Art. 43 assessment where you used one, then walks you through the rest. Export PDF renders the Annex V format with a signature block, and the saved data syncs the Art. 47 obligation.

CE marking is a separate act

Art. 47 and Art. 48 are two distinct legal acts: the declaration is the document; the CE marking is the visible symbol affixed to the system — or, for a purely digital system, digitally — before market placement, with the notified body's identification number beside it where one was involved. The rest of the chain checks for both: a distributor verifies the marking and the declaration are present (Art. 24(1)), an importer verifies them before placing the system on the market (Art. 23(1)).

Art. 49 registration and the Annex VIII field set

Before placing the system on the market, the provider (or its authorised representative) registers itself and the system in the EU database (Art. 49(1)); the fields are defined by Annex VIII. A provider that has concluded a system is not high-risk under Art. 6(3) also registers it (Art. 49(2)), and a public-authority deployer registers its use (Art. 49(3)). In Veritome this is the EU database registration obligation, which sits in the Register phase and unlocks once the Assess phase is complete.

The pre-filled copy-out sheet

Every system has a printable Annex VIII page — a prescribed document, opened from Documents or from the regulator dossier header — that assembles the field set from data Veritome already holds: provider identity and contact, the authorised representative, the system's name and identification, its intended purpose and Annex III point, the conformity-assessment route and the declaration details, and registration status. A banner counts how many fields are still missing and names the underlying obligations to complete — classification, Art. 43, Art. 47, Art. 13 instructions for use — then you regenerate the page and copy the values into the EU database portal.

Veritome submits nothing to any authority. The sheet is a copy-out, by design: the portal is where the registration happens, and the record of having done it is yours to keep.