Medtech Sector Faces Regulatory Uncertainty, Unfair Bids in Sweden

According to an October 2, 2025, article in Medtech Magazine, the Swedish medical technology sector faces significant challenges stemming from regulatory ambiguity and unfair competition. These issues arise primarily from the increasing prevalence of in-house medical device production within healthcare institutions and deficiencies in public procurement processes. The adoption of technologies such as 3D printing has enabled hospitals to manufacture customized medical tools and devices, leading to a regulatory gray area. As highlighted by Mats Högberg in his Medtech Magazine column, this lack of clear regulatory oversight creates uncertainty that could stifle innovation and foster unfair competitive practices. Högberg argues that ambiguous regulations may hinder progress rather than promote it. Simultaneously, the sector is struggling with abnormally low bids in public procurement tenders. A report by the Swedish Competition Authority (Konkurrensverket) concluded that current provisions within the Public Procurement Act (LOU), the Act on Procurement in the Water, Energy, Transport and Postal Services Sectors (LUF), and the Act on Procurement in the Defence and Security Sector (LUFS) are insufficient to effectively address this issue. The report suggests these regulations are difficult to enforce and fail to adequately safeguard the market from anti-competitive behavior and potential criminal activity. Addressing these challenges necessitates regulatory modernization to ensure a level playing field within the Swedish healthcare sector. Stricter regulations are currently being developed to prevent suppliers from submitting abnormally low bids, with the aim of fostering fairer competition and deterring unscrupulous vendors from securing contracts.