Art. 60a Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes | AI act regulation | AI act

This article creates an optional pathway for Member States to permit real-world testing of high-risk AI systems outside of AI regulatory sandboxes, specifically for AI-enabled products falling under the Union harmonisation legislation in Section B of Annex I.

It sits alongside Article 60, which governs real-world testing more broadly, and acts as a tailored complement to it for this specific category of products.

Member States that take up this option must establish formal frameworks for such testing and notify the Commission before doing so.

Those frameworks must incorporate key safeguards drawn directly from Article 60 and ensure close cooperation between all relevant national authorities.

Important points:

Member States are not obligated to allow this type of testing — it is an opt-in mechanism, and those that choose to participate must individually or jointly adopt a formal real-world testing framework.
Any framework adopted must include a mandatory testing plan agreed with the relevant national authority, effective governance and accountability arrangements, and a high level of protection of health, safety and fundamental rights.
Member States that adopt such frameworks must ensure that all relevant national competent authorities cooperate closely and remove practical obstacles, including those relating to access to physical public infrastructure.

1. Member States may allow, in accordance with this Article, the testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes by providers or prospective providers of AI enabled products covered by the Union harmonisation legislation listed in Section B of Annex I, with a view to assessing and verifying the conformity of those systems with the requirements laid down in Articles 8 to 15.
1. Member States that choose to allow testing as referred to in paragraph 1 shall, individually or jointly, adopt frameworks for real-world testing.
1. Each Member State shall notify the Commission of any real-world testing framework it adopts before implementing it. This shall not affect the competences of the Commission under the Union harmonisation legislation listed in Section B of Annex I.
1. Member States that have adopted real-world testing frameworks shall ensure that the relevant national competent authorities, relevant authorities and public authorities responsible for the management and operation of infrastructure and products covered by Union harmonisation legislation listed in Section B of Annex I cooperate closely with each other in good faith and remove any practical obstacles, including on procedural rules providing access to physical public infrastructure, where this is necessary, to successfully implement those real-world testing frameworks and test AI-enabled products covered by Union harmonisation legislation listed in Section B of Annex I.
1. The frameworks for real-world testing shall lay down the requirements under which testing in real-world conditions shall occur. Those frameworks shall:
  1. include the provision of a mandatory real-world testing plan to be agreed between the provider or prospective provider and the national competent authority or relevant authority in accordance with the Union harmonisation legislation listed in Section B of Annex I;
  2. ensure compliance with the requirements laid down in Article 60(2), (3), (4)(d)-(j) and (5)-(9), where any reference to market surveillance authorities in those provisions shall be read as a reference to the national competent authority or relevant authority, as appropriate in accordance with the Union harmonisation legislation listed in Section B of Annex I;
  3. include effective governance and accountability arrangements;
  4. ensure a high level of protection of health safety and fundamental rights.
1. The real-world testing shall comply with the applicable provisions laid down in the Union harmonisation legislation listed in Section B of Annex I. Any requirements laid down in those provisions shall not affect the application of this Article to the extent necessary to enable the testing referred to in paragraph 1.