Article 43 sets out which conformity assessment procedure must be followed before a high-risk AI system can be CE-marked and placed on the market. For most Annex III systems, providers may choose Annex VI internal control IF they apply harmonised standards in full; otherwise Annex VII third-party assessment by a notified body is required. Annex III point 1 (biometrics) defaults to Annex VII unless the provider applies harmonised standards. Annex I systems follow the conformity assessment procedure of the underlying product legislation, integrated with the AI Act requirements.
What you must do
- → Identify the correct procedure for your system BEFORE building the technical file.
- → If using harmonised standards to claim Annex VI eligibility, document the application in detail.
- → Engage the notified body early — capacity is limited and lead times are long.
The authoritative text of Article 43 is published by the Publications Office of the European Union on EUR-Lex. We link directly to it rather than mirror it, so you always read the current consolidated version straight from the source.
Read Article 43 on EUR-LexSource: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act). The only authentic version is the one published in the Official Journal of the European Union.
Conformity Assessment Procedure Selector
Before a high-risk AI system can be placed on the EU market, Art. 43 requires the provider to complete the correct conformity assessment — either internal control (Annex VI) or third-party assessment by a notified body (Annex VII), depending on the Annex III category and the use of harmonised standards. Choosing the wrong procedure invalidates the CE marking and exposes you to withdrawal orders.
Notified Body Finder
When Annex VII third-party conformity assessment is required, you must engage a notified body designated under the AI Act for your specific Annex III category. The wrong body invalidates the assessment. Bodies are listed in the Commission's NANDO database.