The European Union (EU) has announced new restrictions that will limit access to public contracts valued at €5 million or more for Chinese economic operators in the medical device sector. Specifically, medical devices that originate from China will be restricted to a maximum of 50% of the total value of contracts in tenders submitted by other suppliers. These regulations will take effect ten days after the publication of the Commission Regulation on 30 June 2025 and will remain in force for five years, with the option for a five-year extension.
This initiative is grounded in the EU’s International Procurement Instrument (IPI), which was implemented in 2022, aiming to promote reciprocity while opening public procurement markets in third countries to EU businesses. Should any country’s procurement procedures be determined to include discriminatory measures or practices, the EU reserves the right to limit access to its public procurement processes for goods, services, and tenderers from that nation. This represents the inaugural application of the IPI.
In April 2024, the European Commission commenced an investigation into various alleged discriminatory practices in the Chinese market, including advantages granted to domestic devices and services, restrictions on the procurement of imported goods through administrative barriers, and the imposition of unreasonable purchasing requirements, such as obligations to transfer technology to Chinese entities.
While the Commission engaged in negotiations with China to address and rectify these discriminatory practices, no mutually acceptable resolution was achieved. A report released in January 2025 by the Commission highlighted that China’s policies significantly hinder the access of EU businesses and EU-manufactured medical devices to China’s public procurement market. These practices are pervasive throughout China and affect all categories of medical devices. Notably, the Commission found that 87% of public procurement procedures for medical devices in China include terms that limit or discriminate against imported goods.
Furthermore, there are currently no bilateral commitments relating to public procurement between the EU and China, and China is not a signatory to the WTO’s plurilateral Agreement on Government Procurement (GPA).
