Pre-conformity mock assessment protocol (PR-43-MOCK)

PR-43-MOCK is a dry run of the Art. 43 conformity assessment route of a high-risk AI system: internal control under Annex VI, or assessment of the quality management system and the technical documentation under Annex VII. It applies to Annex III and Annex I Section A systems. The protocol selects the route, checks each annex point against the evidence, re-runs a sample of the tests named in the obligation records, and produces a findings register, an evidence-pack index and a remediation plan. It issues no certificate and no declaration.

Protocol PR-43-MOCK: identification
Field	Value
Protocol	PR-43-MOCK
Version	v1.0
Articles	Art. 43
Derived from	Annex VI Annex VII Article 43

PR-43-MOCK v1.0 is built from Art. 43 of Regulation (EU) 2024/1689, Annex VI of Regulation (EU) 2024/1689 and Annex VII of Regulation (EU) 2024/1689; the presence checks for the EU declaration of conformity, the CE marking plan and the registration record follow Art. 47 with Annex V, Art. 48, and Art. 49 with Annex VIII of the same Regulation.

Scope

The protocol covers a high-risk AI system for which the provider prepares a conformity assessment under Art. 43. That is an Annex III system classified under Art. 6(2), or an Annex I Section A system classified under Art. 6(1). The route follows the classification, so the protocol is relevant from the Annex III application date 2027-12-02Deferred for Annex III systems and from the Annex I date 2028-08-02Deferred for Annex I Section A systems.

The protocol covers three groups of elements. First, the route rules in Art. 43(1) to 43(4): which annex applies, and when a substantial modification starts a new assessment. Second, each point of Annex VI and Annex VII as an assessor would check it: the quality management system against Art. 17, the technical documentation against Chapter III Section 2, the consistency between the documented process and the actual process, data access, surveillance and change notification. Third, the presence of the three items that follow a positive assessment: the EU declaration of conformity under Art. 47, the CE marking plan under Art. 48 and the registration record under Art. 49. Within the second group the protocol samples the testable elements of the Art. 9, Art. 10, Art. 11, Art. 12, Art. 13, Art. 14, Art. 15 and Art. 17 records and re-runs the sample with the protocol named on each obligation page.

The protocol is a dry run. It is not a conformity assessment under Art. 43, and AIAssuranceLabs is not a notified body. The protocol does not issue a certificate, does not issue or sign the EU declaration of conformity, does not affix the CE marking and does not register the system. Its result carries no presumption of conformity: no harmonised standard is cited in the Official Journal as of the anchor date, so Art. 40(1) gives no presumption to any system today. The service scope is stated on what we cannot do.

Verified on 18 September 2026last full verification run, see the change log

As of that date, Art. 43(1) sends an Annex III point 1 system to Annex VII unless a common specification under Art. 41 is available and applied. The protocol does not cover systems the provider has concluded are not high-risk under Art. 6(3); PR-CLS v1.0 covers that determination. The protocol does not cover the full test procedures of the sampled records; the named protocols do.

Articles covered

The first table lists the route rules and the annex points as the elements the dry run checks. The second table lists the obligation records the dry run samples, with the protocol that tests each record in full.

Articles covered
Article	Testable element	Steps
`Art. 43(1)`	Route for an Annex III point 1 system: Annex VI or Annex VII where a harmonised standard or a common specification was applied in full; Annex VII where none was applied, or applied only in part, or none exists	3, 4, 6
`Art. 43(2)`	Route for an Annex III points 2 to 8 system: internal control under Annex VI, with no notified body	2, 4
`Art. 43(3)`	Route for an Annex I Section A system: the sectoral conformity assessment procedure, with the Chapter III Section 2 requirements and Annex VII points 4.3 to 4.5 applied within it	4, 5
`Art. 43(4)`	A substantial modification after placing on the market starts a new conformity assessment; a pre-determined change described in the technical documentation does not	30, 31
`Annex VI point 1`	The internal control procedure covers points 2 to 4 for the requirements of Chapter III Section 2	10, 16
`Annex VI point 2`	The established quality management system meets Art. 17	11, 13
`Annex VI point 3`	The technical documentation shows that the system meets each requirement of Chapter III Section 2	15, 16, 18, 21
`Annex VI point 4`	The design and development process and the Art. 72 post-market monitoring match the technical documentation	22, 23
`Annex VII point 3.1`	The quality management system application holds the provider identity, the list of systems covered, the technical documentation of each, the Art. 17 documentation, the procedure that keeps the system adequate, and the declaration that no other notified body received the application	12
`Annex VII point 3.2`	The quality management system is assessed against Art. 17 with conclusions and a reasoned decision	11
`Annex VII points 3.3 and 3.4`	The approved quality management system is maintained; a change to it, or to the list of systems, is notified and examined for re-assessment	13, 14
`Annex VII points 4.1 and 4.2`	The technical documentation application holds the provider identity, the declaration that no other notified body received it, and the Annex IV documentation	15
`Annex VII point 4.3`	The assessor has full access to the training, validation and testing data sets, through an API or other remote means where relevant	19
`Annex VII point 4.4`	The assessor can require further evidence or further tests, and can run tests directly where the provider's tests do not satisfy it	17, 18
`Annex VII point 4.5`	The assessor can access the training methodology, the trained model and its parameters after other means are exhausted, with intellectual property and trade secret safeguards	20
`Annex VII point 4.6`	The decision states conclusions and a reasoned assessment; a certificate follows a positive decision and a reasoned refusal follows a negative one	16, 36
`Annex VII point 4.7`	A change that affects the requirements or the intended purpose is notified; the assessor decides between a new assessment under Art. 43(4) and a supplement	30, 31
`Annex VII points 5.1 to 5.3`	Surveillance of the approved quality management system: access to design, development and testing premises, periodic audits, and an audit report	28, 29
`Art. 47` with `Annex V`	A written, machine-readable EU declaration of conformity exists for the system and holds the Annex V content; presence and content are checked; the declaration is never issued	24, 25
`Art. 48`	The CE marking is affixed visibly, legibly and indelibly, or digitally through the interface; the plan is checked; the marking is never affixed	26
`Art. 49` with `Annex VIII`	The provider registers itself and the system in the EU database before placing on the market, with the Annex VIII Section A data; an Annex III point 2 system registers at national level under Art. 49(5)	27

Articles covered
Record	Elements sampled	Tested in full by	Steps
Art. 9	Every `testable` element of the Art. 9 record: consistent performance per operating condition, prior defined metrics and thresholds, residual risk against the acceptance criterion, activation of each technical measure, behaviour under foreseeable misuse, and vulnerable-group cases	PR-17-QMS v1.0, PR-15-ROB v1.0	17, 18, 35
Art. 10	Every `testable` element of the Art. 10 record: representativeness, error rate and completeness, statistical properties, setting coverage, disaggregated bias examination, mitigation effect, feedback-loop check, and special-category data handling	PR-10-BIAS v1.0	17, 18
Art. 11	Every `testable` element of the Art. 11 record: declared values against test reports, subgroup accuracy, versions, architecture, intended purpose across documents, datasheets, oversight and cybersecurity measures, signed test logs, lifecycle changes, standards list, and the declaration copy	PR-11-DOC v1.0	15, 16, 17, 18, 21, 25
Art. 12	Every `testable` element of the Art. 12 record: automatic recording, continuity after an update, decision reconstruction, risk-indicator events, modification events, post-market monitoring data points, deployer access, and Annex III point 1(a) fields	PR-12-LOG v1.0	17, 18
Art. 13	Every `testable` element of the Art. 13 record: declared accuracy, robustness and cybersecurity against test results, declared circumstances reproduced, subgroup performance, and each instructions-for-use statement against Annex IV	PR-11-DOC v1.0	17, 18, 21
Art. 14	Every `testable` element of the Art. 14 record: interface tools, monitoring of an injected anomaly, automation-bias measure, interpretation tools, override and disregard, stop function, and two-person verification	PR-14-OVR v1.0	17, 18
Art. 15	Every `testable` element of the Art. 15 record: held-out accuracy, distribution shift and versions, perturbation and malformed input, fail-safe takeover, feedback loop, each Art. 15(5) attack class, and detection and response	PR-15-ROB v1.0	17, 18, 35
Art. 17	Every `testable` element of the Art. 17 record: modification record per release, design verification, quality control, test records at the stated frequency, dataset records, serious-incident walk-through, record retrieval, and accountability roles	PR-17-QMS v1.0	11, 13, 17, 18, 29

Inputs required

Inputs required
Input	Format	Provided by
Classification memo naming the Annex III point or the Annex I Section A entry	Document; the `PR-CLS` output where one exists	Client
Technical documentation under Art. 11 and Annex IV	Document set with a version identifier per document	Client
Quality management system documentation: policies, procedures and instructions under Art. 17(1)	Document set with a version identifier per document	Client
Test reports and test logs named in the technical documentation	Dated and signed reports; log export in the schema the documentation names	Client
Instructions for use under Art. 13	Digital document, current release	Client
Draft EU declaration of conformity	Document in the Annex V structure, signed or unsigned	Client
CE marking plan	Document or interface description stating the marking location and form	Client
Registration record or draft with the Annex VIII Section A data	Structured record	Client
Change and release records since the last assessment or since first release	Change log with version identifiers and change classification	Client
Read access to the data sets and, for the sampled re-tests, to the system	Read-only API or environment access, with the safeguards the provider names	Client
Findings-register layout, evidence-pack index layout and severity scale	Templates in this protocol, agreed in step 7	Protocol
Version freeze record	Hash or identifier list produced in step 9	Protocol

Steps

Preparation

Record the system name, version, provider and intended purpose from the general description in the technical documentation.
Record System identification sheet
[Regulation (EU) 2024/1689, Annex IV section 1(a)]
Record the classification basis: the Annex III point or the Annex I Section A entry, from the classification memo.
Record Classification reference, with the PR-CLS output where one exists
[Regulation (EU) 2024/1689, Art. 6(1) and 6(2)]
Record which harmonised standards or common specifications the provider applied, in full or in part.
Record Standards-applied statement; it records that no harmonised standard is cited in the Official Journal
[Regulation (EU) 2024/1689, Art. 43(1)]
Select the route: Annex VI, Annex VII, or the Annex I sectoral procedure with Annex VII points.
Record Route selection record
[Regulation (EU) 2024/1689, Art. 43(1) to 43(3)]
For an Annex I Section A system, record the sectoral procedure and the Annex VII points it incorporates.
Record Sectoral procedure reference with Annex VII points 4.3 to 4.5 marked
[Regulation (EU) 2024/1689, Art. 43(3)]
Where Art. 43(1) allows a choice, record the provider's reason for Annex VI or Annex VII.
Record Route rationale
[Regulation (EU) 2024/1689, Art. 43(1)(a) and (b)]
Agree the findings-register layout, the evidence-pack index layout and the severity scale with the provider.
Record Agreed layouts and severity scale
[AIAssuranceLabs procedure]
Obtain read access to the QMS documentation, technical documentation, test reports, logs and change records.
Record Access log
[AIAssuranceLabs procedure]
Freeze the reviewed set: record the version identifier or hash of each document and system artefact.
Record Version freeze record
[AIAssuranceLabs procedure]
Map each Annex VI or Annex VII point to the steps below and record the map.
Record Coverage map
[AIAssuranceLabs procedure]

Execution

Check that the QMS documentation covers each aspect of Art. 17(1)(a) to (m), and mark each present or absent.
Record QMS coverage table, cross-referenced to the PR-17-QMS gap analysis where one exists
[Regulation (EU) 2024/1689, Annex VI point 2; Annex VII point 3.2]
For Annex VII, check the QMS application contents item by item against point 3.1.
Record QMS application completeness checklist
[Regulation (EU) 2024/1689, Annex VII point 3.1]
Sample one release record and check that the modification-management procedure was applied to it.
Record QMS maintenance sample
[Regulation (EU) 2024/1689, Annex VII point 3.3; Art. 17(1)(a)]
Check that the QMS change-notification procedure names the trigger, the recipient and the decision on re-assessment.
Record Change-notification procedure check
[Regulation (EU) 2024/1689, Annex VII point 3.4]
Check the technical documentation against each Annex IV section and mark each section present, partial or absent.
Record Annex IV completeness index, cross-referenced to the PR-11-DOC output where one exists
[Regulation (EU) 2024/1689, Annex VI point 3; Annex VII point 4.2; Art. 11(1)]
For each Chapter III Section 2 requirement, locate the evidence in the documentation that shows it is met.
Record Requirement-to-evidence map, Art. 9 to Art. 15
[Regulation (EU) 2024/1689, Annex VI point 3; Annex VII point 4.6]
Select a sample of testable elements from the sampled obligation records and record the selection rule.
Record Sample selection record, drawn from the Art. 9 to Art. 15 and Art. 17 records
[AIAssuranceLabs procedure]
Re-run each sampled test with the protocol named on its obligation page and record the result.
Record Sampled re-test result record, one row per element
[Regulation (EU) 2024/1689, Annex VII point 4.4]
Check that each data set named in the datasheets is accessible, through an API where access is remote.
Record Data-set access check
[Regulation (EU) 2024/1689, Annex VII point 4.3]
Record whether access to the training methodology, trained model or parameters would be needed, and the safeguards.
Record Model access necessity note
[Regulation (EU) 2024/1689, Annex VII point 4.5]
Compare the accuracy, robustness and cybersecurity values in the instructions for use with the test reports.
Record Declared-versus-measured comparison
[Regulation (EU) 2024/1689, Art. 13(3)(b)(ii); Annex IV section 2(g)]
Compare the design and development records with the process the technical documentation describes.
Record Design process consistency check
[Regulation (EU) 2024/1689, Annex VI point 4]
Compare the post-market monitoring plan with the monitoring system the technical documentation describes.
Record Post-market monitoring consistency check
[Regulation (EU) 2024/1689, Annex VI point 4; Art. 72(1); Annex IV section 9]
Check that a draft EU declaration of conformity exists and holds each Annex V element.
Record Declaration presence checklist; the protocol does not issue or sign the declaration
[Regulation (EU) 2024/1689, Art. 47(1) and 47(2); Annex V]
Check that the declaration names the same system, version and provider as the general description.
Record Declaration identity match
[Regulation (EU) 2024/1689, Annex IV section 8]
Check that the CE marking plan states where and how the marking is affixed, digitally or physically.
Record CE marking plan check; the protocol does not affix the marking
[Regulation (EU) 2024/1689, Art. 48(2) and 48(3)]
Check that a registration record with the Annex VIII Section A data exists for the Annex III system.
Record Registration readiness checklist; for an Annex III point 2 system, the national-level route is recorded instead
[Regulation (EU) 2024/1689, Art. 49(1) and 49(5); Annex VIII Section A]
Check the provider's procedure for giving an assessor access to design, development and testing premises.
Record Premises access procedure check
[Regulation (EU) 2024/1689, Annex VII point 5.2]
Check that an internal audit plan schedules periodic QMS audits and that audit reports exist.
Record Audit plan and audit report check
[Regulation (EU) 2024/1689, Annex VII point 5.3]
List each change since the last assessment and classify it as pre-determined, other, or substantial.
Record Modification register
[Regulation (EU) 2024/1689, Art. 43(4); Art. 3(23)]
For each substantial modification, record the route that applies again and the evidence it invalidates.
Record Re-assessment trigger record
[Regulation (EU) 2024/1689, Art. 43(4); Annex VII point 4.7]

Analysis

Classify each gap as missing evidence, inconsistent evidence or a failed sampled test.
Record Finding type per row
[AIAssuranceLabs procedure]
Assign each finding a severity from the agreed scale and the article or annex point it concerns.
Record Severity and reference per row
[AIAssuranceLabs procedure]
Mark each evidence-pack index entry present, partial or absent, with its location in the documentation set.
Record Evidence-pack index status column
[AIAssuranceLabs procedure]
For each sampled test, record whether the result meets the provider's declared threshold and the threshold's source.
Record Threshold source record
[Regulation (EU) 2024/1689, Art. 9(8)]
Write the dry-run conclusion as conclusions and a reasoned assessment, without a certificate or decision.
Record Dry-run conclusion
[Regulation (EU) 2024/1689, Annex VII point 4.6]

Reporting

Write the findings register with one row per finding in the agreed layout.
Record Findings register (PR-43-MOCK output)
[AIAssuranceLabs procedure]
Write the evidence-pack index with each gap marked and linked to its finding.
Record Evidence-pack index (PR-43-MOCK output)
[AIAssuranceLabs procedure]
Write the remediation plan ordered by severity and by the annex point each finding blocks.
Record Remediation plan (PR-43-MOCK output)
[AIAssuranceLabs procedure]
Write the dry-run review report: route, sampled elements, results, conclusion and the scope statement.
Record Dry-run review report (PR-43-MOCK output)
[AIAssuranceLabs procedure]
State in the report that no harmonised standard is cited in the Official Journal and no presumption of conformity follows.
Record Scope statement in the report, with the verified-on date taken from the regulation data
[Regulation (EU) 2024/1689, Art. 40(1)]
Record the protocol version and the regulation verification date used for the review.
Record Report header
[AIAssuranceLabs procedure]

The findings register uses one row per finding. The layout below is synthetic; the values show the fields, not a result from any system.

Findings register row layout (synthetic)

finding_id | severity | reference                                | type                  | evidence_location                                            | statement                                                                | remediation_owner         | status
F-01       | blocking | Annex VI point 2; Art. 17(1)(d)          | missing evidence      | qms/procedures/testing.md                                    | No examination, test and validation frequency is stated                  | provider role: QMS owner  | open
F-02       | major    | Annex IV section 2(g); Art. 13(3)(b)(ii) | inconsistent evidence | ifu/current.pdf, accuracy section; tests/accuracy-report.pdf | Declared accuracy metric name differs from the metric in the test report | provider role: test lead  | open
F-03       | minor    | Annex V, signatory element               | missing evidence      | declaration/draft.docx                                       | Signatory name and function field is empty                               | provider role: management | open

The evidence-pack index lists one row per artifact an assessor asks for, tied to the route point and the requirement it serves. The layout below is synthetic.

Evidence-pack index layout (synthetic)

index_id | route_point       | requirement          | artifact                                     | location               | status  | finding_id
E-01     | Annex VI point 2  | Art. 17(1)(a)        | Strategy for regulatory compliance           | qms/strategy.md        | present | -
E-02     | Annex VI point 3  | Art. 15(3)           | Accuracy declaration in instructions for use | ifu/current.pdf        | partial | F-02
E-03     | Annex VI point 3  | Art. 12(1)           | Log schema and retention policy              | logging/schema.json    | present | -
E-04     | Art. 47           | Annex V              | EU declaration of conformity (draft)         | declaration/draft.docx | partial | F-03
E-05     | Art. 49(1)        | Annex VIII Section A | EU database registration record (draft)      | -                      | absent  | F-04

Thresholds and criteria

Art. 43, Annex VI and Annex VII set no numeric threshold. Each annex point has a binary criterion drawn from its text: the item is present or absent, the documented process matches the actual process or does not, the declaration holds each Annex V element or does not. Steps 11 to 31 record that criterion per point, and step 33 assigns the severity below.

Thresholds and criteria
Severity	Definition in this protocol
`blocking`	An Annex VI or Annex VII point has no evidence, or a sampled test does not meet the provider's declared threshold.
`major`	Evidence exists and is inconsistent between two documents, or between a document and the system.
`minor`	Evidence exists and is complete; a form, version or traceability element is missing.

The severity scale is the protocol's own definition, agreed in step 7, and has no source in the Act or in a standard.

For the sampled re-tests in step 18, the pass criterion comes from the protocol that tests the record, following the hierarchy on the standards page. No harmonised standard is cited in the Official Journal, so the first level is empty for every sampled record. At the second and third levels, the quality management system check in steps 11 to 14 uses the Art. 17(1) list as its checklist; prEN 18286Published supplies the clause structure that PR-17-QMS v1.0 follows, and ISO/IEC 42001:2023Published supplies the management-system structure at the next level. Neither is cited in the Official Journal. For the accuracy, robustness, bias, logging and oversight samples, the metric sources are those listed on the obligation pages of Art. 15, Art. 10, Art. 12 and Art. 14.

Where no published threshold exists, the provider sets the target and justifies it against the context of use, as Art. 9(8) requires for prior defined metrics and probabilistic thresholds. Step 35 records, for each sampled test, the provider's declared threshold, its source and whether the result meets it. A sampled test with no declared threshold is recorded as a blocking finding against Art. 9(8), because the result cannot be judged.

Outputs

Each artifact is named per the artifact naming rule and feeds a deliverable specified on deliverables.

Outputs
Artifact	Contents	Deliverable
`Route selection record (Art. 43(1) to 43(3))`	Classification basis, standards-applied statement, selected route and the provider's rationale where a choice exists	Dry-run review of the Annex VI or Annex VII route, Pre-conformity mock assessment
`Dry-run review report (PR-43-MOCK output)`	Route, coverage map, per-point results for Annex VI or Annex VII, sampled re-test results, dry-run conclusion and the scope statement of step 41	Dry-run review of the Annex VI or Annex VII route, Pre-conformity mock assessment
`Findings register (PR-43-MOCK output)`	One row per finding: severity, article or annex reference, type, evidence location, statement, remediation owner field, status	Findings register with severity and article reference, Pre-conformity mock assessment
`Evidence-pack index (PR-43-MOCK output)`	One row per artifact: route point, requirement, location, present, partial or absent status, linked finding	Evidence-pack index with gaps marked, Pre-conformity mock assessment
`Remediation plan (PR-43-MOCK output)`	Findings ordered by severity and by the annex point each blocks, with the evidence that closes each	Remediation plan, Pre-conformity mock assessment
`EU declaration of conformity presence checklist (Art. 47 and Annex V)`	Each Annex V element marked present or absent, identity match with the general description	Evidence-pack index with gaps marked, Pre-conformity mock assessment
`Registration readiness checklist (Art. 49 and Annex VIII Section A)`	Each Annex VIII Section A data item marked present or absent; national-level route noted for an Annex III point 2 system	Evidence-pack index with gaps marked, Pre-conformity mock assessment
`Modification register (Art. 43(4))`	Each change since the last assessment, its classification as pre-determined, other or substantial, and the re-assessment trigger record	Substantial-modification impact assessment against Article 43 criteria, Regression testing after substantial modification
`Sampled re-test result record (PR-43-MOCK output)`	One row per sampled element: protocol used, result, declared threshold, threshold source, pass or fail	Delta test report on affected obligations after a model or version change, Regression testing after substantial modification
`Evidence-pack index update (PR-43-MOCK output)`	The index re-issued after a modification, with the invalidated evidence marked and the new evidence linked	Updated traceability matrix and evidence-pack index, Regression testing after substantial modification

Limitations

The protocol is a dry run and shows what an assessor would find in the evidence at one point in time. It is not a conformity assessment under Art. 43, and AIAssuranceLabs is not a notified body. The dry-run conclusion of step 36 is not a certificate, not a Union technical documentation assessment certificate under Annex VII point 4.6, and not a decision that binds a notified body or a market surveillance authority.

The result carries no presumption of conformity. Art. 40(1) grants that presumption only for a harmonised standard cited in the Official Journal, and none is cited as of the anchor date shown in Scope. A dry run against the annex text and the draft standards cannot create that presumption.

The protocol re-runs a sample of the testable elements of the obligation records. It cannot show that every element passes; the protocol named on each obligation page produces the complete evidence for that record. A passing sample shows that the sampled evidence reproduces, and says nothing about the elements outside the sample.

The protocol observes the quality management system at one point in time. Annex VII point 5.3 provides for periodic audits over the lifetime of the approval; one dry run cannot show that the system operates between audits.

The protocol checks that the EU declaration of conformity, the CE marking plan and the registration record exist and hold the required content. It does not issue or sign the declaration, does not affix the marking and does not submit the registration. Those acts remain with the provider under Art. 47, Art. 48 and Art. 49.

The route rules can change. Art. 43(5) and 43(6) allow the Commission to amend Annexes VI and VII and to move Annex III points 2 to 8 systems to the Annex VII procedure by delegated act. The protocol is revised when such an act enters the regulation data; the revision history below records each version.

Sources

Regulation (EU) 2024/1689, consolidated text: EUR-Lex. Art. 3(23), Art. 6, Art. 9(8), Art. 11, Art. 13, Art. 17, Art. 40, Art. 41, Art. 43, Art. 47, Art. 48, Art. 49, Art. 72, Annex IV, Annex V, Annex VI, Annex VII and Annex VIII.
prEN 18286Published Quality management system for EU AI Act regulatory purposes; the clause structure behind the Art. 17 check in steps 11 to 14.
ISO/IEC 42001:2023Published AI management system requirements; the management-system structure at the next hierarchy level.

Revision history

Version 1.0 is the initial version; its anchor is the regulation entry named in the protocol data, and the stamp below renders that entry's verified-on date.

Revision history of PR-43-MOCK
Version	Note	Anchor
v1.0	Initial version, written from the standards in the derivation line as they stood on the verified-on date of the entry.	Verified on 18 September 2026K&L Gates, EU Digital Omnibus on AI Enters Into Force (31 July 2026)