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Conformity Dossiers — Art. 47

Workflow Overview

High-risk AI systems must undergo a conformity assessment before being placed on the EU market or put into service. Depending on the Annex III category, this can be either a third-party assessment by an EU-designated Notified Body, or a provider-led internal assessment for systems not subject to mandatory third-party review. In either case, the result must be captured in a technical dossier and kept for at least 10 years. ActLoom tracks each dossier from draft through to issued status, records the notified body reference when applicable, and archives all supporting evidence.

What this module helps you control

Assessment readiness

You can see whether the evidence set is complete before you engage a notified body or sign internally.

Version discipline

Each dossier can stay tied to a specific system version so you know exactly which release the CE path covers.

Audit traceability

The dossier becomes the place where technical evidence, declarations, and registration references stay linked together.

Operational aspect	What to know in ActLoom
Prerequisites	The AI system should already be classified as high-risk or otherwise in a conformity pathway, with a stable version and supporting evidence available.
Main inputs	Assessment type, covered version, evidence attachments, notified body information when needed, CE status, and EU database registration details.
Main outputs	Conformity dossier, declaration support, CE-readiness tracking, and linked registration references.
Who typically uses it	Provider-side compliance, legal, quality, notified-body coordinators, and product release stakeholders.
Plan access	Conformity workflows are intended for Business and Pro plans where dossier and technical-document readiness are enabled.
Relevant routes	/api/conformity/dossiers, /api/conformity/dossiers/[id]/status, /api/conformity/dossiers/[id]/inspection-zip, /api/ai-systems/[id]/eu-registration

Dossier record fields

Field	Description	Required
AI System	The registered AI system this dossier covers	Yes
Dossier version	Version number linked to a specific model version	Yes
Assessment type	INTERNAL_ASSESSMENT or NOTIFIED_BODY_ASSESSMENT	Yes
Notified body name	Official name of the EU-designated assessment body	If third-party
Notified body reference	Official certificate or notification number issued by the body	If third-party
Status	DRAFT / IN_REVIEW / ISSUED / WITHDRAWN	Auto-managed
Evidence attachments	Technical documentation, risk assessment, test results, QMS records	Yes
Issue date	ISO date when the dossier was granted ISSUED status	Auto-set on issue
Valid until	Expiry date if applicable (for periodic re-certification schemes)	No

Conformity Assessment Workflow

Create Dossier

Open AI System → Conformity Dossiers tab → New Dossier. Select assessment type (internal or notified body) and link a system version.

Attach Evidence

Upload technical documentation, risk assessments (FRIA + impact assessment), test results, dataset documentation, and quality management records.

Submit to Notified Body

If third-party assessment is required, set status to IN_REVIEW and enter the notified body name. ActLoom tracks time spent in review.

Issue Dossier

Once the assessment is complete, set status to ISSUED. ActLoom records the issue date and locks the evidence set for audit integrity.

Declaration of Conformity

ActLoom auto-generates a draft EU Declaration of Conformity (DoC) pre-filled with system details, dossier reference, applicable standards, and signatory fields.

Conformity Dossiers

Recruitment AI v2.1

TÜV SÜD (#0123)

ISSUEDCE: AFFIXED

Credit Risk Scorer

BSI (#0344)

IN_REVIEWCE: PENDING

Fraud Detection ML

Not required

DRAFTCE: NOT_APPLICABLE

Draft → In Review → Approved → IssuedArt. 47

Fig 31. Conformity dossier — Art. 47 workflow from draft to issued with CE marking and EU database registration.

CE Marking

The CE marking is the visible symbol that a product meets EU safety requirements. For high-risk AI systems, CE marking may only be affixed after the conformity assessment is complete and the dossier issued. ActLoom tracks the CE marking status of each high-risk AI system independently from the dossier workflow, ensuring the two milestones are coordinated.

CE Status	Meaning	When does this apply
NOT_APPLICABLE	CE marking is not required for this system	Systems in non-Annex III categories or excluded from CE marking scope
PENDING	Conformity assessment ongoing — CE marking not yet permitted	Dossier in DRAFT or IN_REVIEW state
AFFIXED	CE marking has been applied — system may be placed on the EU market	Dossier issued, Declaration of Conformity signed and filed
WITHDRAWN	CE marking was previously affixed but has been revoked	System recalled, significant modification made, or market withdrawal

Declaration of Conformity

The EU Declaration of Conformity (DoC) is a legally binding statement that the provider assumes full responsibility for the AI system's compliance with the AI Act. ActLoom generates a draft DoC in PDF format containing:

Provider name and address
AI system name, description, and version
Statement of conformity with the EU AI Act
Reference to applicable harmonised standards and technical specifications
Notified body name and certificate reference (if third-party assessment)
Dossier reference number and issue date
Signatory name, role, and date

Significant modifications reset CE marking

Any substantial change to a high-risk AI system's intended purpose, level of risk, or technical architecture constitutes a "substantial modification" under Art. 6. This requires a new conformity assessment and resets the CE marking to PENDING. ActLoom flags affected dossiers when you record a substantial modification on the system record.

EU Database Registration

Providers of high-risk AI systems must register their system in the EU-wide database established under Art. 71 before the system is placed on the market. The database is operated by the European Commission and provides public transparency on high-risk AI systems deployed across the EU. ActLoom stores the resulting EU database registration ID alongside the dossier and includes it in generated technical documentation exports and the Declaration of Conformity.

Registration fields collected by ActLoom

Field	Description
Provider name	Legal name of the provider as it will appear in the EU database
System name	Official product name of the AI system
Risk category	Annex III category selected during system creation
Intended purpose	Precise description of the task the AI system is designed to perform
Countries of intended use	EU Member States where the system will be deployed
Registration ID	ID returned by the EU database after successful registration — stored and linked to the dossier
Registration date	Date of initial registration submission

Registration required before market placement

Art. 71 registration must be completed before a high-risk AI system can be placed on the EU market or put into service by a deployer. Failing to register before market placement can result in a fine of up to €15 million or 3% of global annual turnover, whichever is higher.

Before you mark a dossier as issued

Check that the system description, intended purpose, and covered version are final and internally approved.
Make sure supporting evidence is attached, not just referenced informally in another tool or folder.
Confirm the Declaration of Conformity and CE status are aligned with the dossier status.
Record the EU database reference as soon as it is available so later exports stay consistent.

Related Sections

AI Systems

Go here when dossier quality is limited by weak intended-purpose, role, or classification records.

Documents

Use this when conformity work depends on technical packs, evidence vaults, and controlled exports.

Post-Market Monitoring

Read this when conformity maintenance must continue after deployment, not just before launch.

Artifacts

Use this for the deliverable-level view of FRIAs, dossiers, declarations, and registration-ready records.

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Operational aspect

What to know in ActLoom

Prerequisites

The AI system should already be classified as high-risk or otherwise in a conformity pathway, with a stable version and supporting evidence available.

Main inputs

Assessment type, covered version, evidence attachments, notified body information when needed, CE status, and EU database registration details.

Main outputs

Conformity dossier, declaration support, CE-readiness tracking, and linked registration references.

Who typically uses it

Provider-side compliance, legal, quality, notified-body coordinators, and product release stakeholders.

Plan access

Conformity workflows are intended for Business and Pro plans where dossier and technical-document readiness are enabled.

Relevant routes

/api/conformity/dossiers, /api/conformity/dossiers/[id]/status, /api/conformity/dossiers/[id]/inspection-zip, /api/ai-systems/[id]/eu-registration

Field

Description

Required

AI System

The registered AI system this dossier covers

Yes

Dossier version

Version number linked to a specific model version

Yes

Assessment type

INTERNAL_ASSESSMENT or NOTIFIED_BODY_ASSESSMENT

Yes

Notified body name

Official name of the EU-designated assessment body

If third-party

Notified body reference

Official certificate or notification number issued by the body

If third-party

Status

DRAFT / IN_REVIEW / ISSUED / WITHDRAWN

Auto-managed

Evidence attachments

Technical documentation, risk assessment, test results, QMS records

Yes

Issue date

ISO date when the dossier was granted ISSUED status

Auto-set on issue

Valid until

Expiry date if applicable (for periodic re-certification schemes)

CE Status

Meaning

When does this apply

NOT_APPLICABLE

CE marking is not required for this system

Systems in non-Annex III categories or excluded from CE marking scope

PENDING

Conformity assessment ongoing — CE marking not yet permitted

Dossier in DRAFT or IN_REVIEW state

AFFIXED

CE marking has been applied — system may be placed on the EU market

Dossier issued, Declaration of Conformity signed and filed

WITHDRAWN

CE marking was previously affixed but has been revoked

System recalled, significant modification made, or market withdrawal

Field

Description

Provider name

Legal name of the provider as it will appear in the EU database

System name

Official product name of the AI system

Risk category

Annex III category selected during system creation

Intended purpose

Precise description of the task the AI system is designed to perform

Countries of intended use

EU Member States where the system will be deployed

Registration ID

ID returned by the EU database after successful registration — stored and linked to the dossier

Registration date

Date of initial registration submission