Why is the Commission consulting:

On 24 April 2024, the European Commission (the Commission) launched an investigation pursuant to Article 5(1) of the International Procurement Instrument (IPI) (2) concerning alleged measures and practices of the People’s Republic of China (the PRC) affecting its public procurement market for medical devices.

Following the conclusion of its investigation, on 14 January, the Commission published the investigation report pursuant to Article 5(4) of the IPI (3). In its report, the Commission concluded, first, that the measures and practices identified in the course of the investigation put in place by the PRC with respect to the procurement of medical devices exist, are applied across the entire territory of the PRC and affect all categories of medical devices. Second, these measures and practices clearly result in practice in a serious and recurrent impairment of access of Union economic operators and Union-made medical devices to the public procurement market for medical devices in the PRC. Consequently, the Commission is now assessing whether the conditions laid down in Article 6 of the IPI for the imposition of measures restricting the access of economic operators and medical devices originating in the PRC to the EU procurement market, within the meaning of Article 2(1)(j) of the IPI Regulation (IPI measures), are met.

With the present consultation, the Commission is seeking the views of entities that may be potentially affected by possible IPI measures pursuant to Article 6 of the IPI restricting the access of economic operators and medical devices originating in the PRC to the Union’s public procurement market for medical devices. The Commission is interested to receive comments on such measures from entities that may be potentially affected by them.

Deadline to submit the information:

3 March 2025, 23:59 (CET)

Who is being consulted:

The Commission invites all entities potentially affected by possible IPI measures described below to submit comments.

Context and possible IPI measures in the current case:

Pursuant to Article 6(3) of the IPI, IPI measures must be determined based on the following criteria:

Pursuant to Article 6(9) of the IPI, when determining possible IPI measure(s), the Commission shall opt for the kind of measure(s) that would be proportionate and most effectively remedy the level of impairment of access for Union economic operators in the medical devices sector and of Union medical devices to the public procurement market of the PRC.

Pursuant to Article 6(6) of the IPI, in the present case the Commission is considering whether to restrict the access of economic operators originating in the PRC from public procurement procedures in the EU in all categories of medical devices with an estimated value equal to or above EUR 5 000 000 net of VAT, by requiring all EU contracting authorities and contracting entities to (a) impose a score adjustment on tenders submitted by economic operators originating in the PRC or (b) exclude tenders submitted by economic operators originating in the PRC.

In case one or more IPI measures were imposed, EU contracting authorities and contracting entities would be also obliged to include in the relevant public procurement documents, the obligations set out in Article 8(1) of the IPI.

In this context, the Commission is seeking the views of entities potentially affected by any possible IPI measures the Commission may impose on the effects of such measures.

Use of information and confidentiality

To receive full consideration, written comments should be as detailed as possible and include supporting documents. Comments should be sent by email to TRADE-EU-INTERNATIONAL-PROCUREMENT-INSTRUMENT@ec.europa.eu or alternatively by mail at the following address:

Submissions received pursuant to this consultation shall be used only for the purpose for which they were requested.

The Commission will treat information received on a confidential basis where there are reasonable grounds justifying such confidential treatment. If you wish to treat any part of the information and supporting documents as confidential, please request this explicitly and give reasons for the request. The information or any documents, which contain confidential information, must be labelled ‘Confidential’.

All confidential information shall be accompanied by a non-confidential summary thereof. The summary shall be in sufficient detail to permit a reasonable understanding of the substance of the information submitted in confidence. If it appears that a request for confidentiality is not justified or if the supplier does not furnish a non-confidential summary of it, the Commission may disregard the information in question.

Information submitted to the Commission shall be free from copyrights. Before submitting to the Commission information and/or data, which are subject to third party copyrights, the entities submitting input must request specific permission to the copyright holder explicitly allowing the Commission to use the information and data for the intended purpose.

For more information or should you encounter any problems in filling out the form, please contact:

TRADE-EU-INTERNATIONAL-PROCUREMENT-INSTRUMENT@ec.europa.eu

SUBMISSION FORM

1.   INFORMATION ABOUT YOU:

2.   INPUT

Please provide your inputs and comments.

If you wish to share any supporting documents, please annex them to your submission and indicate to which parts of your input they refer.

(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 (International Procurement Instrument – IPI) (OJ L 173, 30.6.2022, p. 1).

(2)  See Notice of initiation of an investigation pursuant to the International Procurement Instrument concerning measures and practices of the People’s Republic of China in the public procurement market for medical devices (OJ C, C/2024/2973, 24.4.2024, ELI: http://data.europa.eu/eli/C/2024/2973/oj).

(3)  Report from the Commission pursuant to Article 5(4) of Regulation (EU) 2022/1031 on the investigation under the International Procurement Instrument concerning measures and practices of the People’s Republic of China in the public procurement market for medical devices, COM(2025)5 and its Commission Staff Working Document Factual findings of the IPI investigation on the procurement market for medical devices in the People’s Republic of China Accompanying the document Report from the Commission pursuant to Article 5(4) of Regulation (EU) 2022/1031 on the investigation under the International Procurement Instrument concerning measures and practices of the People's Republic of China in the public procurement market for medical devices, SWD(2025)2 – accessible at: https://ec.europa.eu/transparency/documents-register/detail?ref=COM(2025)5&lang=en.