Slovenia - AI Regulation Implementation (85/2025)

Overview

The Act on the Implementation of the (EU) Regulation on Harmonised Rules on Artificial Intelligence (ZIUDHPUI) organises how Slovenia will apply and enforce Regulation (EU) 2024/1689 (the EU AI Regulation). The law does not add new substantive restrictions on AI systems — those are set by the EU Regulation — but specifies which national authorities will act as notifying bodies for different categories of high‑risk systems, which agencies will perform market surveillance and enforcement, and how coordination and financing will operate. The Act also provides for establishment of a national ethics council, regulatory sandboxes, a public register and outreach programmes for SMEs and public authorities. See the official text in the Uradni list and the Ministry announcement: Uradni list RS, No. 85/2025 (ZIUDHPUI) and Ministry for Digital Transformation – announcement, 24 Oct 2025.

Definitions

The Act relies on the terminology of Regulation (EU) 2024/1689; expressions used in the national law mean the same as those in the EU Regulation. Key terms therefore include: 'AI system', 'provider', 'deployer', 'high‑risk AI system' (as defined by Annexes I and III of the EU Regulation), 'notified body/priglasitveni organ', 'market surveillance authority', 'post‑market monitoring', 'regulatory sandbox' and 'national contact point'. The Act adds no new substantive definitions but maps EU Annex categories to specific Slovenian ministries and agencies for administrative purposes; for the EU text see Regulation (EU) 2024/1689 (EU AI Regulation).

Governance and Institutional Framework

The Act designates sectoral competent authorities: the ministry responsible for the internal market (as notifying authority for many Annex I systems), the ministry responsible for infrastructure, the ministry responsible for health and the Public Agency for Medicines and Medical Devices for medical device‑related AI systems. It names market surveillance authorities: AKOS, the Information Commissioner (Informacijski pooblaščenec), Banka Slovenije, the insurance supervision function (referred to through government channels) and the Market Inspectorate. The statute establishes the ministry for digital transformation as the central coordinator and the authority in charge of regulatory sandboxes and an SME outreach programme. The law assigns oversight of conformity assessment bodies to the national accreditation body and instructs the inspectorate for the information society to monitor publicity, literacy and public sector publication duties. Institutional independence is preserved for regulatory agencies; the Act also requires alignment of agency statutes and provides for state budget financing for agency enforcement tasks. See the enacted provisions in the official publication: Uradni list RS (ZIUDHPUI).

Key Focus Areas

The Act focuses on (1) clear allocation of responsibilities for notifying and supervising high‑risk systems; (2) operational arrangements for post‑market monitoring and market surveillance; (3) provisions to enable and supervise regulatory sandboxes (controlled testing environments) to support innovation while ensuring safety; (4) institutional support for public awareness, SME outreach and AI literacy; (5) funding and staffing requirements for supervisory bodies; (6) rules on cooperation and information‑sharing among national supervisors and with the European AI Office and AI Board; and (7) national measures needed to implement enforcement and administrative sanctions compatible with the EU Regulation. The Act explicitly preserves the EU Regulation’s substantive categories — prohibited uses, high‑risk systems and transparency obligations — and concentrates national measures on enforcement, administrative procedure, and support mechanisms for compliance. For the EU framework and timelines see the AI Regulation (EU) and the Ministry materials (Digitalisation – GOV.SI).

Implementation Framework

The Act sets out concrete administrative steps: ministries and sectoral agencies are listed as notifying authorities for specific Annex categories of the EU Regulation (e.g., market ministry, infrastructure, health, medicines agency). It requires the national accreditation body to evaluate conformity assessment bodies. Agencies named as market surveillance authorities are empowered to use authority deriving from existing inspection and technical conformity acts; where sectoral rules apply (banking, insurance) relevant sectoral legal procedures and sanctions regimes supplement the AI enforcement powers. The Act mandates that AKOS act as the single contact point for industry and the public to provide information and access to sandboxes and support. Agencies must align their statutes and be allocated budgetary resources (state funds) sufficient to carry out their responsibilities. Where the Act refers to procedural law (e.g., administrative procedure, inspection acts), it instructs agencies to follow those laws for enforcement actions, appeals, and judicial review. See the text in the Uradni list for article‑level detail: ZIUDHPUI (Uradni list RS).

Monitoring and Evaluation

The Act requires post‑market monitoring arrangements consistent with the EU Regulation: market surveillance authorities must maintain records, request documentation (including technical documentation generated under the AI Regulation), and report significant incidents. The national inspectorate for the information society is charged with oversight of public sector transparency obligations and literacy measures; agencies are required to cooperate and exchange findings. The Act instructs the national accreditation body to assess conformity bodies and report deficiencies. Agencies will participate in EU‑level cooperation mechanisms (AI Board, European AI Office) and share data through the EU high‑risk systems database when required by the EU Regulation. Periodic reporting and coordination meetings are mandated to evaluate resource sufficiency and enforcement outcomes.

Penalties, Liability, and Appeals

The Act implements administrative enforcement measures and specifies which national authorities may impose sanctions for breaches of obligations under the EU Regulation. It does not substitute the monetary penalty scales set in the EU Regulation (e.g., tiered fines for banned practices, high‑risk non‑compliance and reporting failures), but it provides the procedural basis for imposing administrative fines, corrective measures, orders to cease deployment, recalls, and publication of non‑compliance. Where sectoral supervisors (e.g., Banka Slovenije or the insurance supervision authority) are responsible, the Act directs the use of sectoral enforcement powers and remedies under banking, consumer credit or insurance law. The Act also clarifies appeal routes: where administrative appeal is not permitted (certain agency decisions), judicial review is available. The detailed penalty formulas are governed primarily by the EU Regulation and by the relevant sectoral national laws referenced in the Act.

Relationship to Other Instruments

The Act explicitly references Regulation (EU) 2024/1689 and aligns national administrative procedures with existing Slovenian laws (laws on electronic communications as applicable to AKOS, banking law for Banka Slovenije, insurance law for AZN, and inspection laws for inspectorates). It also requires agencies to apply existing technical conformity, accreditation and inspection laws when exercising powers under the Act. Where the EU Regulation amends or interacts with other EU legal instruments referenced in the Act, the national law points to the applicable domestic statutes for procedural detail. In short, the Act is a coordination and allocation instrument linking the EU Regulation to the domestic institutional and procedural framework; it neither duplicates nor modifies the EU substantive rules.

International Alignment

The Act ensures Slovenia’s compliance with EU obligations and cooperation with EU‑level bodies. It mandates that national supervisors participate in EU coordination mechanisms and share documentation necessary for cross‑border enforcement, consistent with Article 70+ of the EU Regulation. The law supports information exchange with the European AI Office, the AI Board and other Member State authorities, and it establishes national points of contact to facilitate cross‑border market surveillance and conformity assessment recognition. Additionally, by enabling sandboxes and outreach, the Act seeks to align national innovation policy with EU innovation support measures.

Implementation Timeline

Sources and References