What we cannot do

What we cannot do

• We do not perform conformity assessments where a notified body is required.
• We do not issue CE marking or the EU Declaration of Conformity.
• We are not a notified body.
• We do not give legal opinions on classification or liability.
• We test against requirements, prepare evidence, and structure documentation; compliance decisions remain with the provider or deployer, their notified body, and their counsel.

Read the full statement

What each limit means in an engagement

Conformity assessment where a notified body is required

Art. 43(1) of Regulation (EU) 2024/1689 sets the conformity assessment route for a high-risk AI system: internal control under Annex VI, or assessment of the quality management system and the technical documentation by a notified body under Annex VII. The choice of route and the assessment itself belong to the provider and, where Annex VII applies, to the notified body the provider engages. The pre-conformity mock assessment runs PR-43-MOCK v1.0 as a dry run of the same route and produces a findings register, an evidence-pack index and a remediation plan. The dry run issues no certificate and replaces no assessment under Art. 43.

CE marking and EU declaration of conformity

Art. 47 of Regulation (EU) 2024/1689 requires the provider to draw up a written EU declaration of conformity for each high-risk AI system and to keep it at the disposal of the national competent authorities; by drawing it up, the provider assumes responsibility for the system's conformity with Chapter III Section 2. Art. 48 governs the affixing of the CE marking by the provider once the assessment is complete. AIAssuranceLabs drafts neither document and affixes no marking. What it supplies is the evidence pack whose index names each document the declaration rests on, its version, its source protocol and the gaps that remain.

Notified body status

Art. 29 to Art. 39 of Regulation (EU) 2024/1689 set out how a conformity assessment body applies to the notifying authority of its Member State, the requirements it meets under Art. 31, and the identification number the Commission assigns under Art. 35. AIAssuranceLabs is not notified under that chapter and performs none of the tasks Art. 34 assigns to a notified body. A test report from AIAssuranceLabs is evidence the provider submits; the notified body reaches its own conclusion on it. Under the Annex VII route the documentation service structures the technical file to Annex IV of the same Regulation with PR-11-DOC v1.0 so that the notified body's review under Art. 11 and Art. 17 starts from an indexed file.

Legal opinions on classification or liability

Classification under Art. 6 of Regulation (EU) 2024/1689 is the provider's decision, and liability follows from the penalty provisions in Art. 99 and from national law. AIAssuranceLabs gives no legal opinion on either. The classification memo from PR-CLS v1.0 is labelled a reasoned technical assessment: it states the question, the evidence read, the reasoning by article, and the conclusion for discussion with counsel. The assessment memo specification shows its sections and a synthetic sample. The nature of every page on this site is stated on the legal disclaimer.

What we do

Each verb below names the deliverable it produces. Every deliverable is specified on /deliverables/ with a synthetic sample.

• We test against the requirement in the article text: test report with a verdict per element.
• We prepare evidence for the technical file: evidence pack with an index.
• We verify a documented property on the running system, for example that a marking survives re-encoding: test report.
• We document dataset origin, collection, preparation and coverage: dataset card per set.
• We measure accuracy, robustness and group disparity on held-out sets: test report with the metric and its criterion source.
• We structure the technical file to the section order of Annex IV of Regulation (EU) 2024/1689: evidence pack index.
• We map each obligation element to the test or document that addresses it: traceability matrix.
• We review against Annex VI or Annex VII of Regulation (EU) 2024/1689 as an assessor would: findings register with severity and article reference.
• We run a versioned protocol from the methodology pages: protocol run record with each step, its configuration and its output.
• We record a fundamental rights impact assessment for a deployer: FRIA record.
• We assemble the documents an assessor or a market surveillance authority asks for: evidence pack.
• We reconstruct a past decision from the logs kept under Art. 12 of Regulation (EU) 2024/1689: decision reconstruction section of the test report.
• We disaggregate performance by the groups named in the intended purpose: dataset profile and disparity table in the test report.
• We check consistency between the documented process and the process in operation: assessment memo or findings register.

Presumption of conformity

Art. 40(1) of Regulation (EU) 2024/1689 gives a presumption of conformity only to a high-risk AI system that conforms to a harmonised standard, or a part of one, cited in the Official Journal of the European Union, and none is cited for the Act as of the anchor date.

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

The drafts of CEN-CENELEC JTC 21, for example prEN 18229-2Draft, and international standards such as ISO/IEC 42001:2023Published supply the metrics, categories and procedures the protocols on this site derive from. A test result against them is evidence for the technical file and carries no presumption under Art. 40 until a standard is cited. The current stage of each document is listed on /standards/.