Confirm the high-risk classification and provider role, then build a for the specific system version. Prepare it before supplying or first using the system, link statements to evidence, and update it when the system changes. These templates support the required assessment; they do not replace it.
1
Section 1
1. Build the technical file
Prepare the Article 11 before supplying or first using a . Keep it current and clear enough for authorities and any notified body to assess compliance. Annex IV sets the minimum information.
The Annex IV template should be maintained as a controlled , with one owner for each field and a direct link to the underlying proof. Link each claim to the system version, test result and approval so reviewers can check it.
Confirm the legal role and high-risk basis before opening the file. These templates are for the provider of a .
A deployer does not inherit the provider file merely by using the system, but Article 25 can make a deployer, importer, distributor, or other third party the provider after rebranding, a substantial modification, or an intended-purpose change that makes the system high-risk.
Record that role decision and the Article 6 route at the front of the file.
For a related to a product covered by Section A of Annex I, Article 11 permits one technical-documentation set containing both the AI Act material and the information required by the applicable product legislation. Keep a requirements index so the combined file shows which evidence answers each regime.
Check the application date and sectoral route before treating this pack as a current release requirement. Under amended Article 113, Chapter III Sections 1-3, except Article 6(5), apply from 2 December 2027 for Article 6(2) Annex III systems and 2 August 2028 for Article 6(1) Annex I systems, subject to transition rules.
Annex I Section B products follow the limited direct application in Article 2(2), rather than the full Article 11 route. Record the controlling provisions beside the file owner.
Amended Article 11 allows SMEs, including start-ups, and small mid-cap enterprises (SMCs) to provide the Annex IV elements in a simplified manner. If the provider chooses this route, it must use the Commission form established for it, and notified bodies must accept that form.
These working templates do not substitute for that form or remove the Annex IV information requirement.
System identity: intended purpose, provider name, version history, release form, hardware or software dependencies, user interface, and instructions for deployers.
Design and development: development methods, third-party or pre-trained components, architecture, design choices, assumptions, optimization targets, expected outputs, and known trade-offs.
Data evidence: training, validation, and testing data descriptions, provenance, selection, labelling, cleaning, representativeness, data gaps, bias checks, and mitigation records.
Testing evidence: validation procedures, metrics for accuracy, robustness, cybersecurity, discrimination impacts, dated and signed test logs, and all test reports.
Control evidence: human oversight measures, input-data specifications, risk management record, cybersecurity measures, relevant lifecycle changes, standards or specifications used, and the .
Post-market evidence: the system used to evaluate performance after market placement, including the Article 72 post-market monitoring plan.
Supports the role-change triggers that can make a deployer, importer, distributor, or other third party the provider responsible for the high-risk technical file.
2
Section 2
2. Assign and track provider duties
Use an evidence register to track Article 16 provider duties. Give each duty an owner, authoritative record, last-review date and pre-release check. Block release when required evidence is missing.
Set the retention period explicitly. Article 18 requires the provider to keep the technical documentation, quality-management documentation, notified-body change records and decisions where applicable, and for 10 years after the system is placed on the market or put into service.
Longer periods may follow from other Union or national law.
Compliance gate: proof that the system meets the Chapter III, Section 2 requirements before release.
Provider identification: name, trade name or trademark, and contact address on the system, packaging, or accompanying documentation where applicable.
Quality management: Article 17 quality management system procedure, scope, management responsibility, and modification-control records.
Documentation retention: Article 18 evidence showing technical documentation, QMS documentation, notified-body decisions, certificates, and EU declarations are kept for the required authority-access period.
Log custody: Article 19 evidence showing which automatically generated logs are under provider control, retention logic, access controls, and authority-response procedure.
Conformity package: conformity assessment record, , CE marking decision, registration record, corrective-action procedure, authority-response pack, and accessibility compliance evidence.
Lists the provider obligations for high-risk AI systems, including QMS, documentation, logs, conformity assessment, declaration, CE marking, registration, corrective actions, and authority cooperation.
Providers of high-risk AI systems shall
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Section 3
3. Record quality management and market-entry checks
Link quality-management procedures to the declaration, marking and registration records. Article 17 requires documented policies, procedures and instructions; Articles 47-49 govern those market-entry records.
For high-risk AI systems that require notified-body involvement, keep the notified-body application, technical documentation submitted, assessment decision, certificate, change notifications, audit reports, and any additional tests or evidence requests together with the same system version.
EN 18286:2026 was cited in the Official Journal on 14 October 2026 by Decision (EU) 2026/2274. Use the working register below to record covered requirements and remaining measures. Presumption of conformity applies only to covered requirements; adopting the standard does not establish whole-Act compliance or replace conformity assessment.
Keep one row per legal requirement and standard part used. These fields and example rows are a working template, not an official form. Check the detailed mapping against an authorised copy of the standard; retain the licensed text in your controlled internal library.
Quality management fields: regulatory strategy, design control, development and validation procedures, data management, risk management, post-market monitoring, serious-incident reporting, authority communication, record-keeping, resources, and management accountability.
EU declaration fields: system name and traceable identifier, provider or authorised representative, sole-responsibility statement, conformity statement, applicable Union law, a data-protection conformity statement where the system processes personal data, standards or common specifications, notified-body details where applicable, place, date, signatory, and signature.
CE marking fields: placement of the marking, digital access path where the system is provided digitally, notified-body identification number where applicable, and promotional-material checks when CE conformity is mentioned.
Registration scope and fields: before market placement or putting into service, providers or authorised representatives register Annex III high-risk systems in the EU database, except Annex III point 2 systems, which are registered nationally. Public-authority deployers register themselves and their use before deployment.
Keep the provider, representative, system identity, intended purpose, operating-logic summary, market status, certificate details where applicable, Member States, EU declaration copy, electronic instructions, and optional additional-information URL current; use the secure non-public route where Article 49(4) applies.
Change-control fields: intended changes, affected documentation sections, standards impact, notified-body notification need, conformity reassessment decision, and release approval.
Standards register identity: system identifier and version, provider, quality-management scope, owner and reviewer.
Standards coverage: identifier, edition, clauses applied, legal article, Official Journal decision, citation date, latest status check and Annex ZA conditions.
Standards evidence and actions: procedure and revision, evidence location and version, conclusion, remaining action, owner, deadline and approval.
Article 11(1), first sentence, example row: clause 8.9.2; conditional coverage only when the technical documentation contains every Annex IV element. Link the complete Annex IV index, current system version, missing-item review and approval. Assign each missing element before claiming this coverage.
Article 17(1), example rows: document the aspects in points (a)-(m), with procedure owners, approved revisions and operating records. Examine, apply and verify each applicable legal requirement separately. For point (g), link evidence that the risk management system complies with Article 9; clause 8.2 alone does not establish that condition.
Article 17(2)-(4), residual rows: Annex ZA does not cover these paragraphs. Record the proportionality assessment under paragraph 2, including resources and rigour; assess whether paragraph 3 sectoral integration or paragraph 4 financial-services treatment applies; record the legal basis, remaining duties, evidence and reviewer decision.
QMS procedure-to-evidence fields: Article 17(1) aspect; responsible role; procedure and approval date; affected system versions; completed design reviews, validation reports, data checks, monitoring records or incident exercises; unresolved findings and corrective actions; next review trigger. Link shared procedures to system-specific records where needed.
Standards review fields: date of the latest Official Journal check, reference still maintained, changed or withdrawn reference, affected coverage rows, replacement measures and release-impact decision. Recheck after changes to the system, QMS scope or standards used.
Article 1 and the Annex cite EN 18286:2026. Article 2 and recital 6 establish effect from publication on 14 October 2026, limited to requirements covered by the standard.
Official publication announcement identifying the Article 17 quality-management standard. Check Annex ZA in an authorised copy for detailed coverage conditions.
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Section 4
4. Keep logs, monitoring and corrective-action records
Continue collecting evidence after release. Article 12 requires automatic logging capability, Article 19 requires retention of logs under provider control, and Article 72 requires active monitoring throughout the system lifetime.
The post-market template should make field data usable. It should identify what is collected, who reviews it, which signals trigger investigation, how deployer feedback is handled, and how the technical documentation is updated when performance, risk, or intended use changes.
Provider-controlled logs must be retained for a period appropriate to the intended purpose and for at least six months unless other Union or national law provides otherwise. That minimum does not authorise retention that conflicts with data-protection law; record the purpose, access controls, deletion rule, and any longer sector-specific period.
Amended Article 72(3) requires Commission guidance including a voluntary monitoring-plan template by 2 September 2027. Keep this provider-designed monitoring record separate from that future Commission template and retain system-specific sources, thresholds, reviewers and corrective-action decisions.
Monitoring plan: sources of performance data, deployer feedback channels, incident intake, sampling method, review cadence, acceptance thresholds, interaction with other AI systems, and documentation update trigger.
Corrective-action record: non-conformity or risk description, cause investigation, affected versions and deployers, corrective action, withdrawal, disabling or recall decision, authority and notified-body notifications where applicable, and closure evidence.
Documentation update trigger: model, data, interface, intended-purpose, performance, cybersecurity, human-oversight, integration, or deployment-context change that affects compliance or the .
Supports log capability, provider log retention, corrective actions, authority cooperation, and post-market monitoring plan requirements.
actively and systematically collect, document and analyse relevant data
5
Section 5
5. Add separate GPAI model records where needed
If you also provide a general-purpose AI (GPAI) model, keep its documentation separate from the high-risk system file. Article 53 and Annexes XI-XII govern model documentation and information for companies integrating the model, subject to the applicable exceptions.
For GPAI models, add a public summary of training content using the Commission template where Article 53(1)(d) applies. Do not merge that public summary with confidential technical documentation; the audiences and disclosure levels are different.
GPAI model documentation: tasks, acceptable-use policies, release date, distribution method, architecture, parameters, input and output types, licence, training and validation information, compute, training time, and energy-consumption information where applicable.
Downstream-provider information: capabilities, limitations, integration requirements, acceptable uses, software versions, and other information needed by system providers to understand and comply with their own AI Act obligations.
Training-content summary: public categories of training content, explanation of unavailable information where justified, update date, and a clear distinction between public summary fields and confidential fields.
Official Service Desk explanation of high-risk AI system registration before placement on the market, putting into service, or certain public-sector deployment.
Explains registration of providers, authorised representatives, deployers, and high-risk AI systems in the EU database before placement or use.
"Registration"
More quoted passages
"registration requirements for high-risk AI systems"
Commission guidance for GPAI provider scope and obligations that may sit beside, but should not be confused with, high-risk AI system provider evidence.
Commission guidance context for GPAI provider obligations, submission routes, and how the Commission interprets the GPAI provider scope.
"general-purpose AI models"
More quoted passages
"Guidelines for providers of general-purpose AI models"
Official publication announcement identifying the Article 17 quality-management standard. Check Annex ZA in an authorised copy for detailed coverage conditions.
Article 1 and the Annex cite EN 18286:2026. Article 2 and recital 6 establish effect from publication on 14 October 2026, limited to requirements covered by the standard.
Lists the provider obligations for high-risk AI systems, including QMS, documentation, logs, conformity assessment, declaration, CE marking, registration, corrective actions, and authority cooperation.
Supports the role-change triggers that can make a deployer, importer, distributor, or other third party the provider responsible for the high-risk technical file.