Recital 27

(27) It is also appropriate to ensure that real-world testing of high-risk AI systems covered by the Union harmonisation legislation listed in Section B of Annex I to Regulation (EU) 2024/1689 is possible. Those systems are subject to the requirements and procedures of the relevant sectoral legislation and are, for most purposes, not directly subject to that Regulation. Those sectoral acts will, in due course, incorporate requirements corresponding to the requirements set out in Articles 8 to 15 of that Regulation. Therefore, it is appropriate to ensure that Member States can allow real-world testing of these AI systems with a view to assessing and verifying the conformity of those systems with the requirements set out in Articles 8 to 15 of that Regulation. If Member States decide to allow such testing, that Regulation should require them to adopt frameworks setting out the detailed requirements for such testing. That Regulation should provide for essential elements to be contained in such frameworks. When designing such frameworks, Member States should ensure a high level of protection of health safety and fundamental rights of natural persons. Before implementing the framework, Member States should notify it to the Commission. The real-world testing should comply with the relevant Union harmonisation legislation listed in Section B of Annex I to Regulation (EU) 2024/1689, including any applicable provisions regarding testing. However, this should not affect the application of the new article regarding real-world testing.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-14 · Text as adopted (Official Journal); later amendments are not incorporated in this text.