The Two Relief Provisions the AI Act Reserves for SMEs (Arts. 11 and 63)
Almost everything published in English about Regulation (EU) 2024/1689 is written to alarm: €35 million fines, obligation checklists, countdowns. In the same text there are two provisions that do the opposite — remove work — and which almost no-one mentions: the simplified technical documentation form in Article 11 and the simplified quality management system in Article 63. Regulation (EU) 2026/1744, the "Digital Omnibus", in force since 27 July 2026, amended both in a favourable direction.
They come in small print. Here is exactly what they say and whom they reach.
| Art. 11 · technical documentation | Art. 63 · quality management system | |
|---|---|---|
| What it simplifies | The form of presenting Annex IV | Elements of Art. 17 |
| Who it covers today | SMEs, start-ups and small mid-cap companies | SMEs only, including start-ups |
| Extra condition | None | Must not have associated or linked enterprises |
| What the Commission must do | A mandatory form if you opt for it | Guidelines on what can be simplified |
| Amended by the Omnibus | Point 10 | Point 26 |
Art. 11: Annex IV and the simplified form
Article 11.1 requires the provider of a high-risk AI system to draw up the technical documentation before placing it on the market and to keep it up to date. The minimum content is Annex IV, and that is where the real work lies: nine sections.
| Section | Content |
|---|---|
| 1 | General description: purpose, versions, hardware, distribution, instructions for use |
| 2 | Development: design and logic of algorithms, architecture, datasets and their provenance, validation, cybersecurity |
| 3 | Monitoring and control: capabilities, limitations, accuracy, foreseeable unintended outputs |
| 4 | Suitability of performance parameters |
| 5 | Risk management system under Art. 9 |
| 6 | Relevant changes during the lifecycle |
| 7 | Harmonised standards applied, or alternative solutions |
| 8 | Copy of the EU declaration of conformity (Art. 47) |
| 9 | Post-market monitoring plan under Art. 72 |
The relief is in the second paragraph of Art. 11.1, fully replaced by point 10 of Regulation (EU) 2026/1744:
"SMEs — including start-ups — and small mid-cap companies may present the elements of technical documentation specified in Annex IV in a simplified manner. To that end, the Commission shall establish a simplified form […]. Where an SME […] opts to present the information required under Annex IV in a simplified manner, it shall use the form referred to in this paragraph. Notified bodies shall accept that form for the purpose of conformity assessment."
Three readings to take slowly.
The Omnibus expanded the eligible persons. The 2024 version oriented the form "to the needs of small businesses and micro-enterprises". It now covers all SMEs and additionally includes small mid-cap companies.
Simplified is the form, not the substance. It simplifies how "the elements of technical documentation specified in Annex IV" are presented. All nine sections are still there; anyone expecting to be excused from documenting the provenance of their training data is in for a disappointment.
Without a form there is no simplified route. The text is imperative: whoever opts for it "shall use the form". Neither the Regulation nor the Omnibus set a deadline for the Commission to establish it. Before planning around it, check whether it has already been published — the single information platform in Art. 62(3)(b) is its natural location — do not take it for granted.
A practical note about the last sentence: that "notified bodies shall accept that form" only matters when there is a notified body — and often there is not. Art. 43.2 subjects Annex III systems, points 2 to 8 — employment, education, essential services — to internal control under Annex VI, "which does not involve the participation of a notified body". There the interlocutor is the market surveillance authority.
Art. 63: the exact scope, which is not what is usually described
In its 2024 wording, Article 63 opened thus: "Micro-enterprises within the meaning of Commission Recommendation 2003/361/EC may fulfil certain elements of the quality management system required by Article 17 […] in a simplified manner, provided they do not have partner enterprises or linked enterprises". Fewer than ten people and nothing more.
Point 26 of the Omnibus replaced that paragraph 1:
"1. SMEs, including start-ups, may fulfil certain elements of the quality management system required by Article 17 […] in a simplified manner, provided they do not have partner enterprises or linked enterprises within the meaning of Commission Recommendation 2003/361/EC. To that end, the Commission shall draw up guidelines on the elements […] that may be fulfilled in a simplified manner […]"
Recital 28 gives the reason: "With the view of facilitating compliance for a greater number of innovators, this possibility should be extended to all SMEs, including start-ups".
It was extended. And there are three limits that fall out of the headline:
- Small mid-cap companies are excluded from Art. 63. They are in Art. 11, Art. 17.2 and Art. 70.8, but not here. Recital 6 says measures for small-scale operators are extended to them "where appropriate"; in the case of Art. 63, it was not appropriate.
- The condition of having no partner or linked enterprises survives — a stricter filter than being an SME.
- Paragraph 2 was not touched. It still says that paragraph 1 does not exempt from "any other requirements or obligations set out in this Regulation, including those set out in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73". Article 11 itself is listed there: simplifying the quality management system does not simplify the technical documentation. They are two independent reliefs.
There is a third, less cited point. Point 11 rewrote Art. 17.2: the application of the quality management system "shall be proportionate to the size of the provider's organisation, in particular where the provider is an SME, including a start-up or a small mid-cap company". This proportionality does not depend on anyone's guidelines and does cover small mid-cap companies.
Who is an SME here: the consolidation trap
The Omnibus inserted two definitions in Article 3 via its point 4, point (b). Verbatim:
"14a) 'micro, small and medium-sized enterprise' or 'SME': a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC; 14b) 'small mid-cap company': a small mid-cap enterprise as defined in point 2 of the Annex to Commission Recommendation (EU) 2025/1099."
Neither was in the 2024 text, which used "SME" and "micro-enterprise" without defining them.
| Category | Staff | Turnover | Balance sheet |
|---|---|---|---|
| Medium (SME) | < 250 | ≤ €50M or | ≤ €43M |
| Small | < 50 | ≤ €10M or | ≤ €10M |
| Micro | < 10 | ≤ €2M or | ≤ €2M |
| Small mid-cap company | < 750 and not an SME | ≤ €150M or | ≤ €129M |
And here is the trap that invalidates self-assessments: being an SME is not determined by your own accounts. Recommendation 2003/361/EC distinguishes in its Art. 3 between autonomous enterprises, partner enterprises (25% or more of capital or voting rights) and linked enterprises (majority of votes, power to appoint or dismiss management, dominant influence). And its Art. 6 specifies how data are calculated: autonomous enterprises use only their own accounts; for partner enterprises, data are aggregated "in proportion to the percentage participation"; for linked enterprises, "100% of the data".
Direct consequence: a subsidiary of 30 people within a large group is not an SME. It consolidates, blows past the 250-employee threshold and is excluded from the simplified Art. 11. A second filter in Art. 3.4 of the Recommendation: an enterprise is also not an SME if 25% or more of its capital or votes are controlled by public bodies or communities, with limited exceptions.
For Art. 63 the filter is even stricter: it is not enough to meet the numbers after consolidation; the enterprise must have no partner or linked enterprises at all. Two small companies 100% owned by the same parent are linked to each other; neither can use Art. 63 even if both are micro-enterprises.
Dates
Point 40 of the Omnibus replaced point (c) of the third paragraph of Art. 113. Chapter III, Sections 1, 2 and 3 — except Art. 6.5 — now reads:
| Route for classification as high-risk | Applies from |
|---|---|
| Art. 6.2 and Annex III (HR, education, credit, essential services…) | 2 December 2027 |
| Art. 6.1 and Annex I (safety components of products) | 2 August 2028 |
Note if your product is in Section B of Annex I. Article 2, paragraph 2, states that AI systems that are safety components of the products listed in Section B of Annex I are subject only to Article 6.1, Article 60a and Articles 102 to 112 — not the full Chapter III. And point 41 of Regulation (EU) 2026/1744 has just moved machinery there, by adding Regulation (EU) 2023/1230. Before preparing for the high-risk regime, check which section of Annex I your product falls under: you may be preparing for something that does not apply to you.
Two clarifications that are often misread. The Omnibus did not amend Annex III: not one entry. It changed the application date of Chapter III, not the list of high-risk systems. And Arts. 11 and 17 are in that Chapter III, Sections 2 and 3, so those are their dates.
Art. 63, on the other hand, lives in Chapter VI, which does not appear in any exception in Art. 113: it has applied from the general date, 2 August 2026. The relief arrives before the obligation it relieves.
What does not change: the sanctioning regime
Art. 99.4 does not mention Art. 11, Art. 17 or Art. 63. Its list is closed: Art. 16 (providers), Arts. 22, 23, 24, a new point (d bis) with Art. 25 paragraphs 2 and 4 — inserted by Omnibus point 38(b) — Art. 26, Arts. 31, 33 and 34, and Art. 50.
That is not impunity: the fine enters through another door. Art. 16 is in the list, and its points (a), (c) and (d) drag in the requirements of Section 2 — where Art. 11 lives — the quality management system in Art. 17 and the retention requirements of Art. 18. In Spain, Draft Organic Law 121/000096 (BOCG Series A No. 97-1, of 12-6-2026), currently being debated, typifies them expressly: its Art. 17.2(a) makes it a serious infringement to breach Chapter III, Section 2 requirements, and its Art. 17.2(b) does the same for breach of Art. 17 of the Regulation. The amendment phase has been extended to 2 September 2026, so the figures may change.
What an SME can prepare today
- Determine whether you are a provider or a deployer. Both reliefs apply to providers; if you only use a third-party system, your articles are Art. 26 and, depending on the case, Art. 27.
- Calculate SME status using consolidation under Art. 6 of the Annex to Recommendation 2003/361/EC — not with the company's own accounts. In writing, with a date: it is a calculation that expires.
- Check separately whether there are any partner or linked enterprises. That is the additional condition for Art. 63 and it is binary.
- Build Annex IV as an index of nine sections. The form will change the format, not the content.
- Write the quality management system using the thirteen points of Art. 17.1, invoking the proportionality of Art. 17.2 and justifying the level of detail chosen.
- Prepare Annex VI, point 2 if your system falls under Annex III, points 2 to 8: verify yourself that the quality management system meets Art. 17 and that the technical documentation supports conformity.
Related
- What is a "small mid-cap company" under the AI Act
- The EU declaration of conformity and CE marking
- Calculate the sanction that would apply to you
Frequently asked questions
Does the simplified quality management system of Art. 63 cover all SMEs?
All SMEs, including start-ups, following point 26 of Regulation (EU) 2026/1744, but only if they have no partner or linked enterprises within the meaning of Recommendation 2003/361/EC. Small mid-cap companies are excluded from Art. 63, though they are included in Art. 11 and Art. 17.2. Before the Omnibus it was only for micro-enterprises.
If I use the simplified Art. 11 form, do I document fewer things?
No. Art. 11.1 allows the elements of Annex IV to be presented "in a simplified manner", not omitted. The nine sections remain the minimum content, including the Art. 9 risk management system and the Art. 72 post-market monitoring plan.
I have 30 employees but I belong to a group. Am I an SME?
Almost certainly not. Article 3, point 14a, refers to Art. 2 of the Annex to Recommendation 2003/361/EC, and Art. 6 of that Annex requires 100% of linked enterprises' data to be aggregated. Once the group is consolidated, the thresholds are exceeded: neither simplified Art. 11 nor Art. 63.
Can I be fined for not having the Art. 11 technical documentation?
Not directly via Art. 99.4, because it does not cite it. The route is Art. 16, which is on that list, and whose point (a) requires compliance with Chapter III, Section 2 requirements, where Art. 11 lives. The ceiling is €15,000,000 or 3% of worldwide business volume; for SMEs and start-ups the lower of the two figures applies (Art. 99.6), and for small mid-cap companies the Art. 99.6a introduced by the Omnibus applies.
Sources
Regulation (EU) 2024/1689 (AI Act), OJEU of 12-7-2024. Art. 11 and Annex IV; Art. 16 points (a), (c) and (d), Art. 17 and Art. 18.1; Art. 43 paragraphs 1 and 2 and Annex VI point 2; Art. 62 paragraphs 2 and 3; Art. 63 paragraphs 1 and 2; Art. 99 paragraphs 3 to 7; Art. 113 paragraphs 2 and 3; Recital 146.
Regulation (EU) 2026/1744 ("Digital Omnibus"), OJEU Series L of 24-7-2026, in force 27-7-2026. Point 4(b) (definitions 14a and 14b); point 10 (Art. 11.1, second paragraph); point 11 (Art. 17.2); point 26 (Art. 63.1); point 29 (Art. 70.8); point 38 points (b) and (c) (Art. 99.4 point (d bis) and Art. 99.6a); point 40 (Art. 113, third paragraph); Recitals 6 and 28.
Recommendation 2003/361/EC (OJ L 124, 20-5-2003). Annex, Art. 2 (thresholds); Art. 3 paragraphs 1 to 4; Art. 6 paragraphs 1 to 3.
Recommendation (EU) 2025/1099 (OJ L, 2025/1099, 28-5-2025). Annex, point 2: "small mid-cap company".
Draft Organic Law 121/000096 (BOCG Series A No. 97-1, 12-6-2026) — UNDER DEBATE, NOT YET LAW. Art. 17.2 points (a) and (b); Art. 30 paragraphs 1 and 8. Amendments extended until 2-9-2026 (file at congreso.es, consulted 29-7-2026).