10 · SME & Start-up Obligations and Relief
- Regulation (EU) 2024/1689, Arts. 56, 57, 62, 63 (verbatim from the OJ PDF) + PE-CONS 30/26 Digital Omnibus final text
- See also: 06 · High-Risk Classification · 07 · Conformity Assessment · 02 · Implementation Timeline
This page has two parts. Part A is the SME/start-up relief that is already law in the base regulation. Part B covers the Digital Omnibus additions in the final PE-CONS 30/26 text. They should still be treated as pending legal effect until OJ publication, but the final text now settles the main dates and SMC definition references.
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. The base Act set the operational deadline at 2 August 2026; PE-CONS 30/26 moves it to 2 August 2027, pending OJ publication.
- 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 relief (final text pending OJ)
Pending OJ publication. PE-CONS 30/26 is the final Digital Omnibus on AI text approved by the Council on 29 June 2026. During this audit no EUR-Lex/OJ publication was found. Treat these provisions as final-text pending legal effect until publication.
The Digital Omnibus package adds SME-oriented relief on top of the base regulation in the final text:
- 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 — PE-CONS 30/26 extends lower-of fine treatment for certain fines to SMCs.
Still to monitor: OJ publication, the final CELEX citation, the Commission's simplified technical documentation form, and any 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 | PE-CONS 30/26 | Pending OJ |
| Simplified technical documentation | SMEs / start-ups / SMCs | PE-CONS 30/26 | Pending OJ |