Article 43: Conformity Assessment for High-Risk AI Systems

Step 1: Is the system high-risk under Article 6? If no → no conformity assessment under Article 43 (may still have transparency or other duties).

Step 2: Which high-risk route? - Article 6(2) / Annex III → go to Step 3. - Article 6(1) / Annex I → integrated assessment with sectoral product law (Step 4).

Step 3: Annex III systems — internal control or notified body? - Annex III point 1 (biometric identification and categorisation): - If harmonised standards (Article 40) or common specifications (Article 41) have been applied → provider may choose Annex VI (internal control) or Annex VII (notified body). - If harmonised standards do not exist, are not applied (in full), or are published with restrictions → Annex VII (notified body) is mandatory. - Annex III points 2 to 8 → internal control per Annex VI (no notified body required).

Step 4: Annex I product-law systems: - One conformity assessment procedure integrating AI Act requirements with the sectoral product law assessment. The notified body already involved under sectoral law also covers AI aspects, provided it meets Article 31(4), (5), (10) and (11) requirements.

Substantial modifications trigger a new conformity assessment regardless of the route (Article 43(4)). Pre-determined changes disclosed in Annex IV technical documentation do not constitute substantial modifications.

Annex VI (internal control) — The provider: - Verifies that the quality management system complies with Article 17 - Examines the technical documentation (Annex IV) for compliance with Section 2 - Verifies that design and development processes and post-market monitoring are consistent - Self-declares conformity and affixes CE marking

Annex VII (notified body) — A designated third party: - Reviews the quality management system and technical documentation - May conduct testing and audits - Issues a certificate (or refuses if non-compliant) - Conducts surveillance activities

The notified body route adds cost and lead time but provides higher assurance and may be contractually required by deployers or expected by authorities.

• Article 6 — Determines whether conformity assessment is needed.
• Article 11 + Annex IV — Technical documentation the assessment examines.
• Article 17 — Quality management system reviewed during assessment.
• Article 40 — Harmonised standards that create presumption of conformity.
• Article 41 — Common specifications as alternative where standards are absent.
• Article 44 — Certificates issued by notified bodies.
• Article 47 — EU declaration of conformity (output of the process).
• Article 48 — CE marking (affixed after successful assessment).
• Article 49 — EU database registration.
• Annex III — The list that triggers Article 43 via Article 6(2).
• Annex I — Product law list for the integrated assessment path.
• Article 113 — Application dates.

The following reproduces the complete text of Article 43 from the English consolidated text of Regulation (EU) 2024/1689 (OJ L 2024/1689).

1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the provider shall opt for one of the following conformity assessment procedures based on:

(a) the internal control referred to in Annex VI; or

(b) the assessment of the quality management system and the assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.

In demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider shall follow the conformity assessment procedure set out in Annex VII where:

(a) harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not available;

(b) the provider has not applied, or has applied only part of, the harmonised standard;

(c) the common specifications referred to in point (a) exist, but the provider has not applied them;

(d) one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the part of the standard that was restricted.

For the purposes of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the notified bodies. However, where the high-risk AI system is intended to be put into service by law enforcement, immigration or asylum authorities or by Union institutions, bodies, offices or agencies, the market surveillance authority referred to in Article 74(8) or (9), as applicable, shall act as a notified body.

2. For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment procedure based on internal control as referred to in Annex VI, which does not provide for the involvement of a notified body.

3. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider shall follow the relevant conformity assessment procedure as required under those legal acts. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply.

For the purposes of that assessment, notified bodies which have been notified under those legal acts shall be entitled to control the conformity of the high-risk AI systems with the requirements set out in Section 2, provided that the compliance of those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure under those legal acts.

Where a legal act listed in Section A of Annex I enables the product manufacturer to opt out from a third-party conformity assessment, provided that that manufacturer has applied all harmonised standards covering all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter.

4. High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure in the event of a substantial modification, regardless of whether the modified system is intended to be further distributed or continues to be used by the current deployer.

For high-risk AI systems that continue to learn after being placed on the market or put into service, changes to the high-risk AI system and its performance that have been pre-determined by the provider at the moment of the initial conformity assessment and are part of the information contained in the technical documentation referred to in point 2(f) of Annex IV, shall not constitute a substantial modification.

5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annexes VI and VII by updating them in light of technical progress.

6. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraphs 1 and 2 of this Article in order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the conformity assessment procedure referred to in Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into account the effectiveness of the conformity assessment procedure based on internal control referred to in Annex VI in preventing or minimising the risks to health and safety and protection of fundamental rights posed by such systems, as well as the availability of adequate capacities and resources among notified bodies.

The recitals in the same consolidated AI Act on EUR-Lex contextualise conformity assessment proportionality, notified body roles, and the biometric identification exception rationale. Use the official preamble on EUR-Lex.