The Article 16 provider checklist: twelve obligations, a status for each, one document

# Article 16 provider checklist

Prepared on  against Article 16 of Regulation (EU) 2024/1689 as amended by Regulation (EU) 2026/1744, both as published in the Official Journal and read on 12 September 2026. Not legal advice.

Chapter III Sections 1 to 3 apply from 2 December 2027 for systems high-risk under Annex III and from 2 August 2028 for systems high-risk under Annex I (Article 113 as amended).

0 of 12 points done, 0 in progress, 12 not started.

## (a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;

Status: Not started
Provisions: Articles 8 to 15
ISO 42001: A.6.1.3, A.6.2.4, A.5.2
Evidence: [to complete]

## (b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;

Status: Not started
Provisions: Article 16(b)
ISO 42001: A.8.2
Evidence: [to complete]

## (c) have a quality management system in place which complies with Article 17;

Status: Not started
Provisions: Article 17
ISO 42001: Clauses 4 to 10, A.2.2
Evidence: [to complete]

## (d) keep the documentation referred to in Article 18;

Status: Not started
Provisions: Article 18
ISO 42001: Clause 7.5, A.6.2.7
Evidence: [to complete]

## (e) when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;

Status: Not started
Provisions: Article 19, Article 12
ISO 42001: A.6.2.8
Evidence: [to complete]

## (f) ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;

Status: Not started
Provisions: Article 43
ISO 42001: Clause 9.2, A.6.2.4
Evidence: [to complete]

## (g) draw up an EU declaration of conformity in accordance with Article 47;

Status: Not started
Provisions: Article 47
ISO 42001: Clause 7.5, A.6.2.5
Evidence: [to complete]

## (h) affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;

Status: Not started
Provisions: Article 48
ISO 42001: A.6.2.5
Evidence: [to complete]

## (i) comply with the registration obligations referred to in Article 49(1);

Status: Not started
Provisions: Article 49(1), Article 71
ISO 42001: A.4.2
Evidence: [to complete]

## (j) take the necessary corrective actions and provide information as required in Article 20;

Status: Not started
Provisions: Article 20, Article 73
ISO 42001: Clause 10.2, A.6.2.6, A.8.4
Evidence: [to complete]

## (k) upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;

Status: Not started
Provisions: Article 21
ISO 42001: Clause 7.5, Clause 9.2
Evidence: [to complete]

## (l) ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.

Status: Not started
Provisions: Directive (EU) 2016/2102, Directive (EU) 2019/882
ISO 42001: A.6.2.2, A.8.2
Evidence: [to complete]

Points still open: (a), (b), (c), (d), (e), (f), (g), (h), (i), (j), (k), (l).

Article 16 applies to the provider; a deployer, distributor or importer that puts its name on the system, substantially modifies it, or changes its intended purpose so that it becomes high-risk takes on these obligations under Article 25(1). Non-compliance with the obligations of providers under Article 16 carries the fines of Article 99(4).

This checklist is written from the text of Article 16 against the statuses given. It is not legal advice; the ISO 42001 references are StandardOS's reading, and the Regulation confers no presumption of conformity on an ISO certificate.