Applies toEUDE

Real-World Testing (Article 60)

Testing in live operation outside a sandbox

TL;DR

Art. 60 EU AI Act (Regulation (EU) 2024/1689) permits Real-World Testing of high-risk AI systems outside regulatory sandboxes — subject to conditions such as notification of the supervisory authority, risk management and protection of the persons concerned.

What is Real-World Testing (Article 60)?

Requirements for Real-World Testing:

  • Written approval from the competent supervisory authority
  • Risk management system (Art. 9)
  • Data protection safeguards for the persons concerned
  • Stop mechanism for critical incidents
  • Documentation of all test data and results
  • Maximum duration: 6 months, extendable once by 6 months

Practical example

A provider of an HR tool tests a new applicant scoring model with 5 customers in a live recruiting workflow. Real-World Testing notification to the Federal Commissioner for Data Protection (BfDI) and to market surveillance. Stop mechanism active at bias values >5%.

Frequently asked questions

Why not use a sandbox?
A sandbox provides neither real data nor real users. For high-risk AI processing applicant profiles, a sandbox is unrealistic.
Fines for infringements?
Art. 60 is not included in the exhaustive list in Art. 99(4)(a)–(g) — that list covers only infringements of Art. 16 (providers), 22 (authorised representatives), 23 (importers), 24 (distributors), 26 (deployers), 31/33/34 (notified bodies) and 50 (transparency), with fines of up to EUR 15 million / 3% of worldwide annual turnover. Infringements of the Real-World Testing obligations (Art. 60) are therefore not covered by the harmonised maximum fines in Art. 99(3)–(5); they are subject to the effective, proportionate and dissuasive penalties to be laid down by the Member States under Art. 99(1). The highest tier (EUR 35 million / 7%, Art. 99(3)) applies exclusively to prohibited AI practices under Art. 5, not to Art. 60.
Who may carry out Real-World Testing?
Providers AND deployers, each with their own notification.

See also

Practitioner note: This article is practice-oriented compliance documentation, not legal advice. We are a compliance specialist, not a law firm. For legally binding information, consult a qualified lawyer.