10 · SME & Start-up Obligations and Relief
- Regulation (EU) 2024/1689, Arts. 56, 57, 62, 63 + Regulation (EU) 2026/1744 (Digital Omnibus on AI)
- See also: 06 · High-Risk Classification · 07 · Conformity Assessment · 02 · Implementation Timeline
This page has two parts. Part A covers SME and start-up relief in the base regulation. Part B covers the additional relief enacted by Regulation (EU) 2026/1744, which entered into force on 27 July 2026.
The regulation uses the Recommendation 2003/361/EC definitions: SME (< 250 staff and ≤ €50m turnover or ≤ €43m balance sheet) and microenterprise (< 10 staff and ≤ €2m turnover/balance sheet). Some reliefs are SME-wide; the lightest touch (simplified quality management) is microenterprise-only.
Part A — In force today (base regulation)
Priority access to regulatory sandboxes (Art. 57 + Art. 62(1)(a))
- Each Member State must establish at least one national AI regulatory sandbox. Regulation (EU) 2026/1744 moved the operational deadline from 2 August 2026 to 2 August 2027.
- SMEs and start-ups with an EU office/branch get priority access to those sandboxes, provided they meet the eligibility and selection criteria (Art. 62(1)(a)). Priority access does not crowd out other SMEs that also qualify.
Reduced conformity-assessment fees (Art. 62(2))
The specific interests and needs of SME providers (incl. start-ups) must be taken into account when setting conformity-assessment fees under Art. 43, reducing those fees proportionately to their size, market size, and other relevant indicators.
Awareness, training & communication channels (Art. 62(1)(b)–(d))
Member States must:
- run awareness-raising and training tailored to SMEs and start-ups;
- provide dedicated communication channels for advice and queries on implementation;
- facilitate SME participation in the standardisation process.
AI Office support (Art. 62(3))
The AI Office must provide standardised templates, maintain a single information platform for all operators, run awareness campaigns, and promote best practice in AI public procurement.
Simplified quality management for microenterprises (Art. 63(1))
Microenterprises (no partner/linked enterprises) may satisfy certain elements of the Art. 17 quality-management system in a simplified manner, per Commission guidelines.
Important limit (Art. 63(2)): this simplification does not exempt microenterprises from any other obligation — explicitly including Arts. 9, 10, 11, 12, 13, 14, 15 (the core high-risk requirements) and Arts. 72, 73 (post-market monitoring and serious-incident reporting). Smaller size eases how you document, not whether you comply.
Proportionality for GPAI providers (Art. 56(5))
For general-purpose AI models, Code of Practice reporting commitments and KPIs must reflect differences in size and capacity between participants — a lighter administrative touch for smaller GPAI providers, not a substantive carve-out from the Art. 53 obligations.
Part B — Digital Omnibus SME and SMC relief
In force. Regulation (EU) 2026/1744 was published in the Official Journal on 24 July 2026 and entered into force on 27 July 2026.
Regulation (EU) 2026/1744 adds SME-oriented relief on top of the base regulation:
- Extended high-risk transition timelines — Article 6(2) / Annex III high-risk Chapter III, Sections 1–3 obligations move to 2 December 2027; Article 6(1) / Annex I moves to 2 August 2028.
- Simplified technical documentation — SMEs, start-ups and SMCs may provide Annex IV technical documentation in a simplified form to be established by the Commission; notified bodies must accept that form.
- SMC recognition — SMC is defined by reference to Recommendation (EU) 2025/1099, not left undefined.
- Sandbox access — the AI Office may establish an EU-level sandbox for Article 75 systems, with priority access for SMEs, start-ups and SMCs; national sandboxes move to 2 August 2027.
- Penalty proportionality — Regulation (EU) 2026/1744 extends lower-of fine treatment for certain fines to SMCs.
- AI literacy — Article 4 now requires providers and deployers to take measures that support the development of AI literacy rather than guaranteeing a sufficient level, while preserving a context-sensitive operator obligation.
Still to monitor: the Commission's simplified technical documentation form and implementation guidance.
Quick reference
| Relief | Who | Basis | Status |
|---|---|---|---|
| Priority sandbox access | SMEs + start-ups | Art. 57, 62(1)(a) | ✅ In force |
| Proportionate conformity-assessment fees | SME providers | Art. 62(2) | ✅ In force |
| Awareness/training/comms channels | SMEs + start-ups | Art. 62(1)(b)–(d) | ✅ In force |
| Simplified QMS | Microenterprises only | Art. 63(1) | ✅ In force |
| GPAI reporting proportionality | Smaller GPAI providers | Art. 56(5) | ✅ In force |
| Extended high-risk timelines | All, benefits SMEs | Regulation (EU) 2026/1744 | ✅ In force |
| Simplified technical documentation | SMEs / start-ups / SMCs | Regulation (EU) 2026/1744 | ✅ In force; Commission form pending |