Declaration of Conformity, CE marking and Annex VIII registration
The provider's Art. 47 declaration, the Art. 48 CE marking, and registering in the EU database with Veritome's pre-filled Annex VIII export sheet.
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.
The Art. 47 declaration
The EU Declaration of Conformity is the provider's formal, signed attestation — issued under its sole responsibility — that the system conforms with the EU AI Act's high-risk requirements and that the Art. 43 conformity assessment was carried out. Veritome's Declaration editor (open it from the system, or from Evidence → Generate document — the Art. 47 template routes there) pre-fills the system name and provider from the live record and the notified body name and 4-digit ID from your Art. 43 pathway wizard, then walks you through provider address, authorised representative, harmonised standards and the authorised signatory. Export PDF renders the declaration in the Annex V format with the statement of conformity and a signature block, and the saved data syncs the Art. 47 obligation on the Conformity & CE marking tab.
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 its documentation. Both must exist before market placement — and the rest of the chain checks for them: distributors verify the marking is affixed (Art. 24), importers verify it before placing the system on the market (Art. 23).
Art. 49 registration and the Annex VIII field set
Before placing the system on the market, the provider registers it in the EU database; the fields to submit are defined by Annex VIII. In Veritome this is the EU database registration tab, which unlocks once the assessment phase gate is green.
The pre-filled export sheet
Every system has a printable Annex VIII export page (linked from the regulator dossier header) that assembles the field set from data Veritome already holds — provider identity, authorised representative, system identity and classification, conformity assessment and 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 IFU — then you regenerate the page and copy-paste the values into the EU database portal. Nothing is submitted to any authority by Veritome itself.