EU green lights restriction to EU public procurement for medical devices and companies from China

Posted on 05.06.2025

Earlier this week, EU Member States approved the adoption of measures under the International Procurement Instrument (IPI), aimed at addressing imbalances in access to public procurement market for European medical devices in China. As a result, entities and medical devices originating from China will face new restrictions in access to EU public tenders.

The move follows an IPI investigation into China’s procurement practices, with the final measures expected to be published shortly in the Official Journal. The IPI measure will take effect ten days after publication and apply only to new tenders.

The restriction will impact economic operators bidding directly from China on public tenders for medical devices (including IVDs) in the EU with an estimated value of €5 million or more. EU contracting authorities must ensure that no more than 50% of a contract’s value is subcontracted to Chinese entities or includes Chinese-origin medical devices.

These rules will apply across all Union contracting authorities, and enforcement will rest with the contracting bodies, which must verify the origin of bidders and devices.

MedTech Europe is awaiting the legal text to further assess the implications of the IPI measure. Further updates will follow once the measures are published.

For more information, please contact Diana Kanecka, Director International Affairs.