Commission has restricted China’s access to the EU’s public procurement market for medical devices
On 20 June 2025, the European Commission (the "Commission") announced its decision to exclude Chinese companies from EU public procurements of medical devices exceeding 5 million euros (net of VAT), with certain exceptions (as further detailed below). This decision follows the conclusions of the first investigation under the International Procurement Instrument (“IPI”).
The Commissioner for Trade and Economic Security said in the Commission’s press release on the decision “Our aim with these measures is to level the playing field for EU businesses. We remain committed to dialogue with China to resolve these issues.” Commission restricts Chinese participation in medical devices procurement, accessed 20.06.25
Background and investigation
The investigation was launched on 24 April 2024. The investigation report, which was published on 14 January 2025, concluded that certain measures and practices exist across China that result in a “serious and recurrent impairment of access” Implementing regulation - EU - 2025/1197 - EN - EUR-Lex, accessed 20.06.25 of EU firms and EU-made medical devices to Chinese government contracts, constituting third-country measures or practices within the meaning of Article 2(1)(i) of the IPI.
According to a Commission report, 87% of public procurement contracts for medical devices in China were subject to exclusionary and discriminatory measures and practices against EU firms and EU-made medical devices. While the Chinese Government engaged in consultations with the Commission pursuant to the IPI, the Commission noted that no firm commitments to address the measures and practices against EU firms and EU-made medical devices were offered. It was on this basis that the Commission made the decision to assess the conditions set out in Article 6 of the IPI with a view to adopting measures against China.
Where, as a result of an investigation, the Commission finds that a third-country measure or practice exists it is to adopt an IPI measure, if it is considered in the interests of the EU. The measure should either: (i) impose a score adjustment on tenders submitted by economic operators of that third country; or (ii) exclude tenders submitted by such economic operators. The measure adopted should be the one that would be proportionate and most effective in remedying the impairment of access for EU firms and EU-made medical devices to the third country, having regard to the existence of alternative sources of supply and the overall interest of the EU in the measure.
Key takeaways from the decision
The Commission’s decision will have no impact on procurements with an estimated value of less than 5 million euros, which the Commission has noted account for around 96% of all EU procurement procedures for medical devices registered in TED between 2017 – 2022 and which represent around 41% of the aggregated value of all procurement procedures organised. On this basis, most procurement procedures organised by contracting authorities and entities in the EU should be unaffected by the new measures.
For procurement procedures with values equal to or above the threshold of 5 million euros, mitigation measures are in place to address the potential of the overall choice of medical devices available being reduced and/or prices being impacted. In summary:
- Bidders outside of China will still be able to submit tenders including medical devices originating in China provided that the proportion of such medical devices originating in China would not represent more than 50% of the value of the contract.
- In cases where only bidders originating in China would be able to meet the tender requirements or to offer the specific medical devices necessary for overriding reasons relating to public interest, contracting authorities and entities are permitted not to apply the measure.
In addition to the mitigation measures, the Commission’s findings indicated that:
- Member States are not dependent on medical devices originating in China.
- There are sufficient alternative sources of supply of medical devices from the rest of the world to address any reduction in supply from China, such that there should be no reduction in the overall availability of the supply of medical devices for EU contracting authorities or significant budgetary impact.
- Public procurement accounts for only 50% - 70% of the total EU market for medical devices (41% of the value of which should not be impacted by the measure), and private procurement will not be impacted. Accordingly, the estimated total reduction in value of imports from China as a result of the measure is around 15% - 20% (~1 billion to 1.2 billion Euros).
It was necessary for the Commission to determine that any measure taken was within the EU’s interest, giving special consideration to the objective of improving access opportunities for the EU to China. Given the estimated value of China’s procurement market (approximately 128 billion euros), the removal of discriminatory barriers to the EU market is said to offset any potential negative consequences of the new measure. In any event the reduction in procurement of medical devices from China is anticipated by the Commission to create opportunities for EU medical device producers, who it is estimated will be able to capture around 60% of the volume that would have originated in China (with the remaining to be captured by third countries) as well as employment opportunities for individuals in the EU.
Despite the decision, the Commission has stated that it remains committed to addressing the discrimination and exclusionary measures and that the withdrawal or suspension of decisions made under the IPI is possible where the measures are satisfactorily addressed.
It will be interesting to see if the position taken by the Commission forces changes in China and achieves the Commission’s ultimate aim of levelling the playing field for the EU.
China’s response and perspective
In response to the EU’s decision, Chinese authorities have criticised the move as a shift towards protectionism. The Ministry of Commerce called it a trade restriction, while the Foreign Ministry urged the EU to respect WTO rules and resolve issues through dialogue.
Chinese industry groups are concerned about the impact on investment and supply chains. Some industry experts note that despite the Commission’s claim of alternative suppliers, Chinese products remain important in areas like affordable diagnostics, PPE, and hospital supplies. A broad exclusion could reduce competition and raise healthcare costs.
So far, China has not taken any concrete retaliatory measures; however, this issue is expected to be discussed at the upcoming China-EU leaders’ summit next month, marking 50 years of diplomatic relations.
China views certain procurement mechanisms - like centralised purchasing and compatibility rules - as policy tools to support public health, quality, and cost control. These are not aimed specifically at foreign suppliers, and many EU companies still operate in China.
Further reading
The full text of the Commission’s press release is available: here
The Commission’s implementing Regulation is available: here
