What proportionate duties and support measures apply to SMEs?

What must Member States do under Article 62?

Article 62(1) requires Member States to undertake four actions for SMEs including startups. They must provide SMEs having a registered office or a branch in the Union with priority access to AI regulatory sandboxes, to the extent that they fulfil the eligibility conditions and selection criteria, without precluding other SMEs that also fulfil the criteria. They must organise specific awareness raising and training activities on the application of the Regulation, tailored to the needs of SMEs including startups, deployers and, as appropriate, local public authorities. They must utilise existing dedicated channels and, where appropriate, establish new ones for communication with SMEs, deployers and other innovators, to provide advice and respond to queries about implementation, including participation in sandboxes. They must facilitate the participation of SMEs and other relevant stakeholders in the standardisation development process. Those duties are framed for Member States, not for the Commission alone, so the detail, the contact points and the timetable will differ between Member States. A small company should identify its Member State measures, the authority responsible and the application route, rather than assuming that a measure described for one Member State is available in another on the same terms.

How are conformity assessment fees made proportionate?

Article 62(2) provides that the specific interests and needs of SME providers, including startups, shall be taken into account when setting the fees for conformity assessment under Article 43, reducing those fees proportionately to their size, market size and other relevant indicators. That provision does not set a fee, a discount percentage or a fee schedule. Fees are set under the conformity assessment system, with notified bodies and national arrangements, and the reduction is proportionate rather than a fixed exemption. A small provider should therefore ask the notified body or the relevant authority, at the start of the conformity process, how fees are set for SME providers, what evidence of SME status is required, and what the fee covers. The answer should be recorded with the date and the contact, because fee arrangements can change and because a later dispute about fees will turn on what was agreed. A provider should not assume that a proportionate fee means a low fee in absolute terms, and should budget for the full cost of the assessment, including the internal time to prepare the file, even where the external fee is reduced. The fee is only one part of the cost of conformity.

For the broader regulatory framework, see SMEs, startups and open source overview.

What simplified documentation and quality arrangements exist?

Simplified arrangements exist in defined places, and they must not be overstated. Article 11(1) as amended allows a simplified form of technical documentation for SME and SMC providers in defined circumstances, with the Commission empowered to specify the simplified form. Article 17(2) as amended requires quality management systems to be proportionate to the size of the provider organisation, and allows a simplified form for SME and SMC providers where the Commission specifies it. Article 63 allows microenterprises to comply with the quality management requirements in Article 17 in a simplified manner, provided that they do not have a partner or linked enterprise, and provided that the simplification does not affect the level of protection or the compliance with high risk requirements. Those provisions are conditional and, in some cases, depend on Commission specification. A small provider should check the consolidated text for the provision it relies on, check whether the Commission has specified the simplified form, and record the simplified arrangement actually used, with the reasoning that it does not reduce protection. A file that is short because it omits required content is not a simplified file in the sense of the Act. It is an incomplete file.

What does the AI Office provide for all operators?

Article 62(3) requires the AI Office to provide standardised templates for areas covered by the Regulation as specified by the Board, to develop and maintain a single information platform providing easy to use information for all operators across the Union, to organise appropriate communication campaigns to raise awareness about obligations, and to evaluate and promote the convergence of best practices in public procurement procedures in relation to AI systems. Those measures are for all operators, not only for SMEs, but they are particularly useful for small teams that do not have a dedicated regulatory function. A small team should check the AI Office platform and the templates on the date it prepares its file, and should record the version used, because templates and platform content are updated. A template is a starting point, not a completed file. The team must adapt the template to its system, its data, its risks and its evidence, and must not submit a template with uncompleted sections or with generic text that does not describe its system. The platform and the templates should be used alongside, not instead of, the consolidated legal text and the applicable standards.

How should a small provider use proportionality in practice?

Proportionality in practice means scaling the effort to the risk, the complexity and the size of the operation, while covering every requirement. A small provider with a single high risk system can have a quality management system that is a single coherent document set, with named responsibilities, procedures and records, rather than a large corporate system with many layers. It can have a technical documentation file that is concise but complete, with each Annex IV element addressed and evidenced. It can have a risk management process that is proportionate to the system, with the hazards, the measures and the residual risk recorded in a form that a reviewer can follow. It can use templates, standards and sandbox guidance, with the source and version recorded. What it cannot do is omit a requirement because the team is small, or record a generic statement where specific evidence is required. The test for proportionality is whether a competent reviewer can follow the reasoning, test the evidence and reach the same conclusion. If the file does not allow that, it is not proportionate. It is incomplete. The file should be reviewed by a person who was not responsible for writing it, even in a very small team, by using an external reviewer where an internal reviewer is not available.

Continue with who counts as an SME.

What does this guide not promise?

This guide does not promise sandbox access, a fee reduction, a simplified form or a template for any named company, and it does not state the availability or detail of any Member State measure. Priority access is subject to eligibility and selection criteria, fees are set under the conformity system, simplified forms depend on Commission specification where the Act provides for it, and templates depend on the AI Office work programme. A small provider should confirm the measure, the conditions and the contact with the national competent authority and the AI Office platform on the date it needs the support. This guide explains the provisions that create the measures, not the measures as they operate in a particular Member State on a particular date.

Frequently asked questions

Continue through this AI Act cluster

• SMEs, startups and open source overview
• who counts as an SME
• small mid-caps
• sandboxes for smaller firms
• simplified quality management for microenterprises
• conformity assessment and CE marking