A brief update on Sweden’s adaptations to the AI Act – SOU 2025:101

In October 2025, the Swedish inquiry (SOU 2025:101) (“SOU”) aiming to investigate the measures necessary to implement the Artificial Intelligence Act, Regulation (EU) 2024/1689 (“the AI Act” or “the Act”), delivered its report. The aim of the inquiry was, among other things, to clarify how responsibilities should be shared between national authorities, to submit proposals on what is needed to meet the requirements for sanctions in the event of violations of the Act and to analyse what is needed to establish regulatory sandboxes for AI.

While the AI Act is directly applicable (and in some parts already in force), a national framework complementary to the Act is proposed. Along with implementation of the main provisions of the AI Act the complementary Swedish law is intended to apply from 2 August 2026. In line with the purpose of SOU, the Swedish Post and Telecom Authority (“PTS”) is proposed as the overall coordinating market surveillance authority and the national single contact point under the AI Act. In addition, several additional market surveillance authorities are designated. Rules on information sharing between the relevant market surveillance authorities are also proposed. Due to its specific competence in relation to, for example, medical devices, the Swedish Medicinal Products Agency is proposed as one of the additional authorities. As regards the med tech and life sciences sectors, it may be worth noting that it is also proposed that the Swedish Medical Products Agency should act as the notifying authority in relation to high-risk AI systems related to products covered by EU regulations on medical devices and in vitro diagnostics. This is in line with the authority’s current responsibilities as supervisory authority over the products mentioned.

On a more general basis, SOU proposes that the market surveillance authorities may decide on intervention measures in cases of any breach of the AI Act. Such measures include administrative fines and reprimands. It is proposed that Swedish authorities, in addition to private entities, may be subject to such measures. This does however not include courts acting in their judicial capacity. In addition, SOU proposes that at least one regulatory sandbox should be established in Sweden by no later than 2 August 2026. In its capacity as the main market surveillance authority, the PTS should establish the sandbox. Other competent market surveillance authorities, such as the Swedish Medicinal Products Agency, will participate in specific sandbox projects.