AI Act
Can my SME use the AI Act's simplified routes?
Article 62 of the AI Act provides specific measures for SMEs and microenterprises. Answer 5 questions to find out which simplified routes apply to your organisation.
Last updated: 12 May 2026
Do AI Act SME derogations need to comply with AI Act?
Article 62 of the AI Act provides specific measures for SMEs and microenterprises. Answer 5 questions to find out which simplified routes apply to your organisation. If yes: Simplified Annex IV documentation available. If not: Simplified documentation not available — full Annex I…
- Yes path: Simplified Annex IV documentation available
- No path: Simplified documentation not available — full Annex IV applies
- Use the step-by-step decision tree below for your exact situation
AI Act · Question 1
Does your organisation qualify as an SME under EU Recommendation 2003/361/EC (≤ 250 employees AND turnover ≤ €50m OR balance-sheet total ≤ €43m)?
The AI Act adopts the standard EU SME definition. Headcount is the primary criterion. Linked enterprises (parent/subsidiary) are consolidated.
For informational purposes only. Consult qualified legal counsel before making compliance decisions.
Decision Criteria & Full Path Breakdown
Review all branch conditions, regulatory criteria, and outcomes assessed by this decision tree.
- 1
Does your organisation qualify as an SME under EU Recommendation 2003/361/EC (≤ 250 employees AND turnover ≤ €50m OR balance-sheet total ≤ €43m)?
The AI Act adopts the standard EU SME definition. Headcount is the primary criterion. Linked enterprises (parent/subsidiary) are consolidated.
If Yes: Proceeds to: Is your organisation a microenterprise (< 10 employees AND turnover ≤ €2m OR balance-sheet total ≤ €2m)?If No: SME derogations not available — standard AI Act regime applies - 2
Is your organisation a microenterprise (< 10 employees AND turnover ≤ €2m OR balance-sheet total ≤ €2m)?
Microenterprises are a sub-category of SMEs and receive additional simplifications under Article 11(1) second subparagraph.
If Yes: Proceeds to: Is your AI system high-risk because it is a safety component of a product covered by Annex I (e.g. medical device, machinery)?If No: Proceeds to: Do you plan to develop, train, or test a high-risk or general-purpose AI system? - 3
Is your AI system high-risk because it is a safety component of a product covered by Annex I (e.g. medical device, machinery)?
Annex I products fall under sectoral EU harmonisation legislation. The simplified documentation route does NOT apply to Annex I (product-safety) high-risk AI systems — only to Annex III use-case high-risk systems.
If Yes: Simplified documentation not available — full Annex IV appliesIf No: Simplified Annex IV documentation available - 4
Do you plan to develop, train, or test a high-risk or general-purpose AI system?
Article 57 establishes AI regulatory sandboxes. Article 62(2)(a) reserves priority access for SMEs and startups.
If Yes: SME priority sandbox access + SME-considerate feesIf No: SME proportionate measures — no derogation from substantive obligations