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Good practice Imported

Trilateral KI-Reallabor Pilot — Germany's Simulated AI Regulatory Sandbox for High-Risk Medical AI

Germany · Wiesbaden · See the Germany profile

Evidence: Descriptive / self-reported Top 24% 73/100 · Ask Evidence Copilot about this practice

Germany's Bundesnetzagentur, Hesse's digitalisation ministry and the federal data-protection commissioner simulated an EU AI Act sandbox with two medical-device start-ups, producing a public roadmap ahead of the deadline for member states to stand up real sandboxes.

2
Start-ups participating in the pilot
~5 months
Pilot duration (May 2025-March 2026)

Details

Maturity
Pilot
Promoter
Bundesnetzagentur (Federal Network Agency), Hessian Ministry for Digitalisation and Innovation, and the Federal Commissioner for Data Protection and Freedom of Information (BfDI)
Period
May 2025–March 2026
Region (NUTS)
DE71
Keywords
AI Act implementation, regulatory sandbox, medical device AI, cross-agency governance, high-risk AI compliance

Context

Ahead of the EU AI Act's deadline for member states to stand up regulatory sandboxes, Germany's Bundesnetzagentur, the Hessian Ministry for Digitalisation and Innovation, and the Federal Commissioner for Data Protection (BfDI) ran a trilateral pilot (May 2025-March 2026) simulating a sandbox with two medical-device start-ups developing high-risk AI systems.

Results

The pilot produced a detailed roadmap on how AI Act conformity requirements intersect with medical-device certification, plus lessons on sandbox-candidate viability, participant needs (confidentiality, structured communication, a maturity model), and cross-agency coordination between a federal regulator, a state ministry and a data-protection authority.

Conclusions

The agencies frame the results explicitly as input to designing Germany's forthcoming statutory AI regulatory sandbox rather than a finished, scaled programme; only two companies took part and the output is procedural guidance rather than a quantified outcome.

Implementation

Implementation detail (cost, timeline, staffing, conditions for success) is not yet available for this practice.

Commonly funded by

National / regional programmes Digital Europe Programme

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Data sources

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