DOES A CONFORMITY-ASSESSMENT DUTY ACTUALLY APPLY?
Start with the real system, intended purpose, high-risk classification route and provider role. Do not assume that every AI system requires the same conformity procedure or CE-marking pathway.
BEFORE YOU PROVE CONFORMITY,
PROVE THE ASSESSMENT ROUTE.
Conformity assessment is not a generic certificate that every AI system buys. For systems where it applies, the defensible work begins by establishing the high-risk route, provider standing, current system baseline and evidence package that the applicable procedure will actually examine.
BOUNDARYThis page is educational and operational guidance. It is not legal advice, certification, conformity assessment or regulatory approval.
CURRENT SOURCE ANCHOR
OPEN OFFICIAL EU SOURCE ↗EUR-Lex · Regulation (EU) 2024/1689 · Conformity framework
Use the current consolidated Regulation, including the high-risk classification and conformity-assessment provisions, as the controlling source. The required route and any notified-body involvement depend on the system and applicable legal framework.
WHAT BUSINESSES NEED TO ESTABLISH
Do not start with a generic checklist.
Start with the actual system, role, use case and evidence boundary. The same regulation can produce different obligations for different actors and systems.
WHAT ASSESSMENT ROUTE GOVERNS THE SYSTEM?
The applicable procedure can depend on how the system is classified and whether it is linked to product-safety legislation or falls within other high-risk routes. Preserve the source and reasoning supporting the selected pathway.
IS THE EVIDENCE PACKAGE CURRENT?
Technical documentation, quality-management controls, risk management, data governance, testing, logs, instructions, human-oversight design and other applicable evidence should be tied to the assessed system version rather than assembled as unrelated files.
WHAT HAPPENS AFTER A MATERIAL CHANGE?
Substantial or material changes can affect the prior assessment position. Preserve the assessed baseline, identify the change and determine whether re-evaluation or a new conformity step is required before relying on the old state.
THE TA-14 OPERATING ROUTE
Turn the question into a governed record.
The goal is not merely to reach an answer. It is to preserve what facts, evidence, scope and limitations supported that answer at that time.
Establish classification and provider standing
Identify the system, version, intended purpose, provider role and the legal basis for treating the system as high-risk before selecting a conformity route.
Map the applicable procedure
Connect the classification route to the current Regulation and relevant harmonisation legislation, standards, common specifications or notified-body involvement where applicable.
Assemble the assessment evidence
Organize technical documentation and supporting governance evidence by requirement, owner, version, provenance and gap so the package can be reviewed rather than merely uploaded.
Preserve declaration, registration and post-assessment state
Where applicable, connect the conformity result to declarations, marking, registration, market-entry state, monitoring and the triggers that would require renewed assessment.
READY TO OPERATE · START PAID ACCESS NOW
Move from reading about the EU AI Act to maintaining the record.
Choose the smallest operating tier that fits the portfolio today. Upgrade when system count, team size or governance scope actually requires it.
Evidence Passport
$19/MOKeep a living system-level evidence record with obligations, gaps, versions and revalidation state.
START EVIDENCE PASSPORT →Compliance Workspace
$49/MOCoordinate evidence, owners, documentation, incidents and team compliance work in one governed workspace.
START COMPLIANCE WORKSPACE →Governance Pro
$99/MOOperate broader high-risk, GPAI, FRIA, post-market and material-change governance across a growing portfolio.
START GOVERNANCE PRO →Institution
$499/MORun institutional governance with expanded users, authority workflows, examiner rooms and portfolio reporting.
START INSTITUTION →Need an independent human readiness examination?A governed readiness review is separate from software access and starts at $750.
REQUEST READINESS REVIEW →Not ready to subscribe? Classify first.
Use the free classifier to establish the system, intended purpose, possible actor role, EU exposure and unresolved facts. When continuing evidence infrastructure is needed, paid access begins at $19 per month. Independent human readiness review remains a separate service.
COMMON QUESTIONS
Questions businesses are asking now.
Does every AI system need an EU AI Act conformity assessment?
No. Conformity-assessment requirements are tied to applicable high-risk and other legal routes. The system, intended purpose, operator role and classification basis should be established before assuming a conformity procedure applies.
What is EU AI Act conformity assessment?
It is the process used where applicable to demonstrate that a covered high-risk AI system satisfies the relevant requirements before the required market or service step. The exact procedure depends on the legal route and current Regulation.
Does conformity assessment always require a notified body?
No. The Regulation provides different conformity pathways. Whether third-party notified-body involvement is required depends on the system and applicable procedure, including interactions with relevant Union harmonisation legislation.
Is CE marking the same as EU AI Act compliance?
No. CE marking is part of specified conformity and market-entry frameworks where applicable. It should not be treated as a universal statement that every governance, deployment or lifecycle obligation has been satisfied.
Can TA-14 perform a notified-body conformity assessment?
No. TA-14 is not presented as a notified body. It can help structure system identity, applicable requirements, technical-documentation evidence, provenance, gaps, changes and readiness so the organization can prepare for the appropriate assessment route.
What happens if the AI system changes after assessment?
Changes should be evaluated against the assessed baseline and applicable legal rules. Where the change affects the prior conformity position, the organization should preserve that trigger and determine what re-evaluation is required before continuing reliance.