Limits to medical devices from China in EU tenders

The European Commission (the “EC”) has adopted Commission Implementing Regulation (EU) 2025/1197 of June 19, 2025 (OJEU L 2025/1997, of June 20; “Implementing Regulation 2025/1197”), restricting the access of economic operators and medical devices originating in the People’s Republic of China (“PRC”) to the European Union public procurement market. These restrictions will come into force on June 30, 2025.

Context

In April 2024, the EC launched the first investigation on its own initiative under Regulation (EU) 2022/1031, of June 23, 2022 (OJEU L 173, of June 30, the “International Procurement Instrument” or “IPI”). The purpose of the investigation was to obtain information and verify whether certain practices and measures by the PRC’s authorities were making it difficult for or preventing European companies from participating in the PRC’s public procurement market for medical devices.

According to the EC, the investigation confirmed the reality of those measures, which result in a “serious and recurrent” impairment of the access of EU economic operators and goods to the Chinese market. Similarly, the EC stated that the Chinese authorities have not submitted any commitments or specific solutions during this period for remedying this unstable situation.

Given the circumstances, the EC has adopted Implementing Regulation 2025/1197, placing restrictions on the participation of economic operators and medical devices originating in the PRC in EU tenders.

Restrictions

Implementing Regulation 2025/1197 establishes the following restrictions:

• All bids submitted by economic operators originating in the PRC will be excluded from all public procurement procedures in the EU that are aimed at the procurement of medical devices falling under CPV codes 33100000-1 to 33199000-1 as defined in Regulation (EC) No. 2195/2002 (OJEU L 340, of December 16), and with an estimated value equal to or greater than €5 million, excluding VAT.
• If the bid is submitted by an economic operator from a country other than the PRC, under article 8 IPI, the bids made to public tenders that are selected cannot include a percentage above 50% of goods or medical devices originating in the PRC.

According to section 2.2 Implementing Regulation 2025/1197, the EC does not expect the restrictions to negatively affect the availability of supply sources. Without prejudice to that, we must consider that article 9 IPI establishes two exceptions to the application of restrictive measures for specific cases, including when there are no viable alternatives to the devices affected by the restrictions due to overriding reasons relating to the public interest.

Entry into force and scope of restrictions

Implementing Regulation 2025/1197 and the restrictions it establishes will come into force on June 30, 2025, 10 days after its publication in the OJEU.

These restrictions will apply to “all Union procurement procedures concerning all categories of medical devices” (recital 33 Implementing Regulation 2025/1197). This results in obligations and new responsibilities for “all Union contracting authorities and contracting entities” (article 1.2 Implementing Regulation 2025/1197) and bidding companies.

The contracting authorities and entities must follow and apply these restrictions, include the measures in the respective tendering specifications, and verify that the medical devices originating in the PRC they purchase do not represent 50% of the total (article 2 Implementing Regulation 2025/1197).

Also, all economic operators (e.g., manufacturers and distributors) that participate in the tender procedures and supply goods of Chinese origin must abide by the new restrictions. In this case, the bidding companies may have to reconfigure their strategy or re-design their offer, as well as adopt measures enabling traceability of the origin of the products offered for the purpose of the 50% maximum limit.