EU imposes first International Procurement Instrument measure restricting Chinese access to medical devices procurement
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On 19 June 2025, the European Commission (the “Commission”) adopted a measure in its first investigation under the EU’s International Procurement Instrument ("IPI")1 to exclude Chinese medical device suppliers from EU public contracts worth more than €5 million for the next five years, effective 30 June 2025.
Background
Adopted in 2022, the IPI allows the Commission to investigate alleged non-EU country measures or practices against EU economic operators that limit access to the public procurement and concession markets of non-EU countries. If it finds problems in non-EU country procurement, the Commission has the power to impose measures ("IPI measures") to restrict access to companies from the non-EU country in EU public tenders. Once imposed, IPI measures may remain in force for five years, with the possibility of a five-year extension.2
On 24 April 2024, the Commission launched its first investigation under the IPI concerning the practices and measures of the Chinese public procurement market for medical devices (see our previous alert here).
On 14 January 2025, the Commission concluded that the existence and application of certain Chinese measures and practices (e.g. the 'Buy China' policy and centralised volume-based procurement) limit the access of EU medical devices and suppliers to the Chinese procurement market (see our previous alert here).
On 2 June 2025, EU Member States voted in favour of imposing IPI measures against Chinese medical device producers operating on the EU public procurement market. Following this decision, on 19 June 2025, the Commission formally imposed IPI measures3 in the form of an exclusion of tenders submitted by Chinese economic operators in EU public tenders with a value equal to or above €5 million. These measures will come into effect on 30 June 2025. Below, we discuss both the scope of these IPI measures and the Commission’s assessment supporting their adoption.
The scope of IPI measures on Chinese medical devices
An IPI measure may take the form of either a score adjustment or the exclusion of tenders. The Commission considered that the former option would only have a limited effect and would not effectively remedy the level of impairment of access identified in relation to the Chinese public procurement market for medical devices.
Hence, the Commission considered that an IPI measure in the form of exclusion of tenders would be more appropriate. The scope of the measure covers all EU procurement procedures: (i) concerning all categories of medical devices falling under CPV codes 33100000-1 to 33199000-14; (ii) organised by all EU contracting authorities and contracting entities; (iii) with a value equal to or above €5 million, net of VAT; and (iv) affecting all economic operators originating in the PRC.5
Commission’s assessment
In line with the IPI Regulation,6 the Commission examined (i) the proportionality and adequacy of the possible IPI measures, (ii) the availability of alternative sources of supply, and (iii) EU interest in imposing IPI measures. The Commission’s assessment is summarised below.
1. Proportionality
The Commission concluded that China has put in place an overarching system of generally applicable preferences for domestic medical devices, which affects the totality of medical devices originating in the EU, without any threshold and irrespective of whether they are offered by EU bidders (see our previous alert here for a summary of these measures and practices).7
The scope of the IPI measures is limited to public procurement procedures with an estimated value of €5 million or more (net of VAT), which represent approximately 59 per cent. of the total value of the EU medical device procurement market. Moreover, tenderers may still include medical devices from China in their offers, as long as they represent no more than 50 per cent. of the total contract value.8
The Commission therefore found that even the most comprehensive IPI measure would be less far-reaching and exclusionary than the policies and practices implemented in China.9 Hence, the Commission considered that an exclusion of tenders is adequate and proportional in relation to the identified impairment of access.
2. Availability of alternative sources of supply
The Commission considered that the proposed IPI measure would not have a negative impact on the supply of medical devices for contracting authorities in the EU. The key reasons are provided below:
- Most tenders are not affected by the IPI measure: Most procurement procedures for medical devices include values below the €5 million threshold.10
- Partial inclusion is allowed: Chinese-origin medical devices can still represent up to 50 per cent. of the contract value in tenders affected by the IPI measure.11
- No dependency is identified and alternative sources of supply are available: The volume of medical devices affected by the IPI measure could easily be replaced by EU production or imports from other non-EU countries.12
3. EU interest
Finally, the Commission concluded that the adoption of the IPI measure is in line with the interests of EU economic operators, EU contracting authorities and the EU economy. The IPI measure could serve as an important leverage for China to remove its restrictive measures and practices and to improve market access opportunities for EU economic operators in the medical devices sector.13
What comes next?
The IPI measure will last five years but may in certain circumstances be terminated earlier, or extended:
- The Commission may withdraw or suspend the application of the IPI measure during the five-year period, if the Commission considers that China (i) takes satisfactory corrective actions to eliminate or remedy the impairment, or (ii) undertakes commitments to end the identified measures or practices.
- The IPI measure may be extended for another five years, following a Commission review (initiated no later than nine months before the date of expiry of the IPI measure).
1 Regulation (EU) 2022/1031 of the European Parliament and of the Council of 23 June 2022 on the access of third-country economic operators, goods and services to the Union’s public procurement and concession markets and procedures supporting negotiations on access of Union economic operators, goods and services to the public procurement and concession markets of third countries (the “IPI Regulation”), available here.
2 Article 6 of the IPI Regulation.
3 Commission Implementing Regulation (EU) 2025/1197 of 19 June 2025 imposing an International Procurement Instrument measure restricting the access of economic operators and medical devices originating in the People’s Republic of China to the European Union public procurement market for medical devices pursuant to Regulation (EU) 2022/1031 of the European Parliament and of the Council (the “IPI Measure”), available here.
4 As defined in Regulation (EC) No 2195/2002.
5 IPI Measure, Recital 33, Article 1 and Article 2.
6 Article 6(2) and (3) of IPI Regulation.
7 See IPI Measure, Recital 21.
8 See IPI Measure, Recital 22 and 23.
9 See IPI Measure, Recital 24.
10 See IPI Measure, Recital 34.
11 See IPI Measure, Recital 36.
12 See IPI Measure, Recitals 38 – 42.
13 See IPI Measure, Recital 57.
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