Template
EU AI Act Article 43 - Conformity Assessment Template
Article 43 is where the package has to state how conformity assessment is handled before the system is placed on the market or put into service. The requirement is procedural and system-specific: the record has to match the route actually used for the relevant AI system.
Technical contribution: Evidence-backed scaffold
Who supplies what
What Article 43 expects, what the template can add, and what your team still owns
This template helps capture the conformity-assessment route in writing. It does not decide which route applies to your system and it does not perform the assessment for you.
| Article 43 expects | What the template can add | What your team still has to write | Practical output to keep |
|---|---|---|---|
| A stated conformity-assessment route | A dedicated section for the procedure used for the relevant AI system. | State which conformity-assessment route applies and why. | A conformity-assessment section in the package. |
| Evidence of readiness before market placement or service | A place to cross-reference the documentation and supporting materials used in the assessment. | List the actual documents, tests, and approvals used for the system. | A referenced conformity file list. |
| Any notified-body involvement where applicable | Prompts for the part of the route that involves external review. | Record whether a notified body is involved and capture the relevant reference details when applicable. | A notified-body note, if applicable. |
| System-specific status and date | A structured section for current assessment status. | Record the real status, date, and owner for the assessment work. | A dated status record. |
Manual fields
What your team still adds to Article 43
Conformity assessment is not generated from runtime artifacts alone. The template can structure the section, but your team still has to state the route actually used and the status of the work.
| What you add | Why it is required | Practical format to use |
|---|---|---|
| Assessment route used | The package must reflect the actual conformity-assessment procedure applied. | A short route statement naming the procedure used. |
| Current assessment status | The package should show where the system stands in the procedure. | A dated status note with owner. |
| Notified-body details where applicable | Some routes require external review details. | A short external-review reference note. |
| Cross-reference to supporting documents | The assessment section needs links to the underlying materials. | A short list of the linked documents used in the assessment. |
FAQ
Frequently asked questions
What is the Article 43 - Conformity Assessment template page for?
This page explains what the Article 43 - Conformity Assessment template section usually needs to cover inside an EU AI Act package, which parts can be supported by structured evidence, and which parts remain owned by the provider, deployer, or legal reviewer.
Does this Article 43 - Conformity Assessment template page create a complete EU AI Act package?
No. It is one section-level guide. A review-ready package still needs the selected role and scope, the other applicable article-level sections, linked technical evidence, owner completion, and final human review.
What evidence should be linked to the Article 43 - Conformity Assessment template section?
Use evidence that is current, traceable to the relevant system version, and connected to real runs, retained records, or approved procedures. A weak package relies only on narrative text; a stronger package links the narrative to reproducible artifacts.
Who should review the Article 43 - Conformity Assessment template section before handoff?
The technical owner should confirm the system facts and evidence links, while compliance or legal reviewers confirm whether the section is sufficient for the selected EU AI Act role, scope, and conformity path.