EU restricts Chinese participation in medical device procurement

The European Commission has announced a new measure restricting Chinese companies from participating in EU public procurement procedures concerning medical devices. This decision, made under the International Procurement Instrument (IPI), excludes Chinese economic operators from all EU procurement procedures concerning medical devices valued over €5 million, with exceptions only where no alternative suppliers are available. Bidders originating outside China will still be able to submit tenders including medical devices originating in China, provided that the proportion of medical devices supplied originating in China does not represent a value above 50 % of the total value of the contract.

The Commission’s action follows the findings of its first investigation under the IPI, which revealed that 87% of public procurement contracts for medical devices in China were subject to exclusionary and discriminatory practices against EU suppliers. The primary aim of the measure is to encourage China to remove its discriminatory barriers and provide EU companies with reciprocal access to its procurement market.

The implementing regulation imposing the measure enters into force on the 30 June 2025 and will be in force for five years, with the possibility of an extension of a further five years. Contracting authorities must after entry into force determine the origin of the economic operators and medical devices that may be covered by the IPI measure, calculate the relevant estimated values of the contracts, and where needed comply with the requirements, for example to exclude a supplier from a procurement procedure in certain cases, or to impose a score adjustment on the supplier’s tender offer.

Please do not hesitate to contact Setterwalls if you have any questions about the measures or what it means for your business.