Strategic Benefits & Practical Considerations (Regulatory Sandbox)
Sandbox participation provides direct regulatory feedback on the system’s compliance approach before the conformity assessment, reducing the risk of failed assessment or post-market enforcement. It creates a documented track record of regulatory cooperation, strengthens credibility with market surveillance authorities, and may benefit from Article 57(8)'s regulatory flexibility provisions.
Sandbox programmes typically run six to twelve months and require dedicated effort: application preparation, regular progress reporting, test result sharing, and issue escalation. Organisations should reserve sandbox participation for their highest-risk or most novel systems, where regulatory uncertainty is greatest. Lower-risk systems with well-understood compliance pathways are better served by standard internal conformity assessment.
Sandbox findings and supervisory feedback are integrated into the AISDP. Where the competent authority has reviewed and accepted specific aspects of the system’s design, the Legal and Regulatory Advisor documents this acceptance as supporting evidence. Sandbox exit reports are valuable Module 10 artefacts.
Key outputs
- Sandbox participation for highest-risk or most novel systems
- Six-to-twelve-month commitment with regular reporting
- Supervisory feedback integrated into the AISDP
- Module 10 AISDP evidence
Sandbox Does Not Constitute Conformity Assessment
Sandbox participation, however constructive, does not constitute conformity assessment under Annex VI or Annex VII. A system that has completed a sandbox programme must still undergo the full conformity assessment before it can be placed on the market. Supervisory feedback received during the sandbox is evidence that supports the assessment; it does not replace the assessment.
Organisations should be explicit about this distinction internally. A Business Owner who believes that sandbox completion equates to market readiness will be disappointed. The Conformity Assessment Coordinator clarifies the relationship between sandbox participation and conformity assessment during the delivery planning phase.
The sandbox’s value lies in de-risking the conformity assessment by identifying and resolving compliance issues early, not in bypassing the assessment altogether.
Key outputs
- Clear distinction between sandbox participation and conformity assessment
- Sandbox as assessment de-risking, not replacement
- Internal communication to Business Owner on the distinction
- Module 10 AISDP documentation