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

• CELEX: Implementing Regulation (EU) 2025/1197
• Articles: 3

Article 1

1.   An International Procurement Instrument measure (‘IPI measure’) in the form of exclusion of tenders within the meaning of Article 6(6), letter b) of Regulation (EU) 2022/1031 submitted by all economic operators originating in the People’s Republic of China is imposed in all public procurement procedures in the Union having as subject matter the procurement of medical devices falling under CPV codes 33100000-1 to 33199000-1 as defined in Regulation (EC) No 2195/2002 and with an estimated value equal to or above EUR 5 000 000 net of VAT.

2.   The IPI measure referred to in paragraph 1 shall apply to all Union contracting authorities and contracting entities, without prejudice to Article 7 of Regulation (EU) 2022/1031.

Article 2

1.   Union contracting authorities and contracting entities as well as successful tenderers shall comply with the requirements laid down in Article 8 of Regulation (EU) 2022/1031 with respect to public procurement procedures falling withing the scope of the IPI measure referred to in paragraph 1 of Article 1.

2.   Union contracting authorities and contracting entities shall:

(a)

determine the origin of the economic operators and medical devices that may be covered by the IPI measure in accordance with the criteria set out in Article 3 of Regulation (EU) 2022/1031 and Article 60 of Regulation (EU) No 952/2013 of the European Parliament and of the Council  ( 41 ) , respectively;

(b)

calculate the relevant estimated values of the contracts in accordance with Article 5 of Directive 2014/24/EU.

Article 3

This Regulation shall enter into force on the tenth day following that of its publication in the Official Journal of the European Union .