Procurement of medical devices: New measures between the EU and China
Measures imposed by the EU
On 30 June 2025, several measures entered into force that were imposed by the European Commission regarding the purchase of medical equipment originating from China.
The following two measures apply:
- Exclusion of offers from Chinese companies in public procurement for medical equipment with an estimated value of at least EUR 5,000,000 (excl. VAT);
- Other bidders may propose medical devices of Chinese origin for these procurements, but they may not account for more than 50% of the estimated contract value.
Bidders must therefore ensure that goods and services of Chinese origin do not exceed 50% of the total contract value during the contract period, and for this, sufficient evidence must be provided. If the share exceeds 50%, a penalty will be imposed.
These measures are included in the 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 (“Implementing Regulation 2025/1197”).
Implementing Regulation 2025/1197 is based on the International Procurement Instrument (IPI). The IPI aims to improve access for European companies to public procurement in third countries. Third countries are all countries that are not EU Member States, are not members of the Government Procurement Agreement (GPA), or do not have a trade agreement with the EU.
The instrument allows for the imposition of trade restrictions within Europe when third countries exclude European companies from public procurement.
The European Commission determined, following an investigation in 2024, that such restrictions were being applied by China in its public procurement market for medical devices, systematically favouring domestic products.
The Implementing Regulation 2025/1197 includes exclusion measures for tenders submitted by companies from China for public contracts involving medical devices falling under CPV codes 33100000-1 through 33199000-1. This includes scanners, prosthetics, medical consumables, medical instruments, and clothing for medical personnel.
In some exceptional cases, the contracting authority may decide not to apply the measure:
- If only valid offers were submitted by Chinese economic operators because they are the only ones that can meet the requirements; or
- For compelling reasons of public interest, such as public health or environmental protection.
The measures only apply to procurement procedures published on or after 30 June 2025.
China’s countermeasure
In response to the measures imposed by the EU, China issued a countermeasure. As of 6 July 2025, companies established in the EU are excluded from Chinese public procurement for medical equipment if the value exceeds 45 million yuan (EUR 5.3 million). However, companies with European capital that are established in China are still allowed to participate.
Another restriction is that, in offers from non-European companies, the share of EU-imported products may not exceed 50% of the total contract value.
Conclusion
Contracting authorities must take the exclusion measures into account when purchasing medical devices. They must reference Implementing Regulation 2025/1197 and the underlying IPI in their procurement documents.
Bidders must pay close attention to the fact that their offer may not contain medical equipment of Chinese origin that exceeds 50% of the estimated contract value.
Your ALTIUS team will keep you informed and is available for any questions.
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