REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL pursuant to Article 13 of Regulation (EU) 2022/1031 on the application of this Regulation and on the progress made in international negotiations, regarding access for Union economic operators to the public procurement or concession markets of third countries, undertaken under this Regulation
Date: 2025-07-30
Institutions: Directorate-General for Trade and Economic Security, European Commission
Subjects: China, goods and services, international trade, market access, public procurement, restriction on competition, service concession, services contract, tendering, third country

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 30.7.2025  COM(2025) 430 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL pursuant to Article 13 of Regulation (EU) 2022/1031 on the application of this Regulation and on the progress made in international negotiations, regarding access for Union economic operators to the public procurement or concession markets of third countries, undertaken under this Regulation  
 
 
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)1 (‘the IPI Regulation’) 
was published in the Official Journal of the European Union on 30 June 2022 and entered into 
force on 29 August 2022. 

Article  13  of  the  IPI  Regulation  requires  the  European  Commission  (‘the  Commission’)  to 
submit, by 30 August 2025 and at least every two years thereafter, a report to the European 
Parliament and to the Council on the application of this Regulation and on the progress made 
in  international  negotiations,  regarding  access  for  Union  economic  operators  to  the  public 
procurement or concession markets of third countries, undertaken under this Regulation. This 
report is to be made public by the Commission.  

The IPI Regulation also mandates the Commission to establish certain tools to facilitate the 
application  of  the  Regulation.  The  Commission  has  complied  with  these  requirements  and 
Section  1  outlines  the  corresponding  measures  taken.  Since  the  entry  into  force  of  the  IPI 
Regulation,  the  Commission  has  initiated  and  concluded  one  IPI  investigation  concerning 
measures and practices of the People's Republic of China (‘the PRC’) in the public procurement 
market  for  medical  devices.2  This  first  IPI  investigation  is  presented  in  Section  2.  Finally, 
Section  3  below  provides  the  Commission’s  conclusions  based  on  its  experience  with  the 
application of the IPI Regulation up to the date of this report. 

1.  Tools to facilitate the application of the IPI Regulation 

The Commission has made available to all relevant stakeholders a number of tools to facilitate 
the application of the IPI Regulation, in the form of operational guidelines, guidance, and two 
online tools: a complaint tool aimed for parties potentially affected by procurement restrictions 
abroad,  and  an  explanatory  tool  aimed  to  facilitate  the  implementation  of  IPI  measures  by 
Union contracting authorities. 

1.1. Commission guidelines to facilitate the application of the IPI Regulation by contracting 
authorities and contracting entities, and by economic operators 

Article 12 of the IPI Regulation  requires  the Commission to  issue  operational  guidelines to 
facilitate the application of the Regulation by contracting authorities and contracting entities, 
and by economic operators, within six months from its entry into force. The Commission has 
complied  with  this  requirement  by  publishing  such  guidelines  on  21  February  2023  (‘the 
Guidelines’).3 

The  Guidelines  provide  guidance  to  contracting  authorities  and  contracting  entities  in 
determining the origin of the economic operators, goods and services. For economic operators, 
the criterion is the place of constitution, and the Guidelines provide an explanation of the notion 

1   OJ L 173, 30.6.2022, p. 1, ELI: http://data.europa.eu/eli/reg/2022/1031/oj. 
2   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 (C/2024/2343), OJ C, C/2024/2973, 24.4.2024,  
ELI: http://data.europa.eu/eli/C/2024/2973/ojhttp://data.europa.eu/eli/C/2024/2973/oj. 

3   Communication  from  the  Commission  ‘Guidelines  to  facilitate  the  application  of  the  IPI  Regulation  by 
contracting authorities and contracting entities and by economic operators’ (2023/C 64/04), OJ C 64, p. 7, 
21.2.2023, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52023XC0221(02). 

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of ‘substantial business operation’, introduced to prevent circumvention of the IPI Regulation 
through the use of shell companies. In the case of goods, the origin is established in accordance 
with the non-preferential rules of origin under the Union Custom Code.4 As for services, the 
origin is determined by that of the services supplier. 

Finally,  the  Guidelines  clarify  the  rules  for  the  application  of  IPI  measures  by  contracting 
authorities and contracting entities, including valuation rules to determine if the value of the 
contract is below or above the thresholds for the application of IPI measure(s) under Article 6 
of the IPI Regulation. They set transparency requirements in the public procurement procedures 
to  apply  IPI  measures  (score  adjustment  measures  and  exclusions)  and  explain  the  rules 
regarding the application of IPI measures to specific contracts such as framework contracts.  

1.2. The Online Complaint Tool 

Article 5(1), second subparagraph, of the IPI Regulation requires the Commission to make an 
online tool available on its website for Union interested parties and Member States to formally 
submit a substantiated complaint, which can lead the Commission to initiate an investigation 
into  an  alleged  third-country  measure  or  practice. The  Commission  has  complied  with  this 
obligation  by  making  available  an  online  complaint  tool  (‘OCT’).5  The  OCT  contains 
mandatory  fields  such  as  the  identity  of  the  complainant,  information  about  the  complaint, 
factual  description  of  the  third-country  measure  and/or  practice  and  optional  fields  (e.g. 
economic  or  systemic  impact  of  the  measure,  bidding  experience  and  actions  already 
undertaken or planned). The Commission has introduced robust safeguards to ensure a very 
high  standard  of  confidentiality  and  anonymity  in  the  handling  of  complaints. To  date,  the 
Commission has not received any  substantiated complaint via this dedicated OCT. At the same 
time, the Commission has received a number of informal complaints about public procurement 
barriers in third-countries via other channels.  

1.3.  Guidance  for  interested  parties  to  provide  information  under  Article  5(1)  of  the  IPI 
Regulation 

According to Article 5(1) of the IPI Regulation, the notice of initiation of and IPI investigation 
shall  invite  interested  parties  and  Member  States  to  provide  relevant  information  to  the 
Commission within a specified period of time. In order to inform interested parties about how 
to  make  themselves  known,  and  to  structure  the  collection  of  information  from  interested 
parties and Member States, the Commission has published a guidance for interested parties to 
provide information.6 

1.4. The “Procurement4Buyers” online tool 

Albeit not required by the IPI Regulation, the Commission has made publicly available on its 
website  a  procurement  tool  that,  inter  alia,  informs  contracting  authorities  and  contracting 
entities  when  they  must  restrict  the  participation  of  foreign  bidders  in  accordance  with  IPI 
measures.  In  order  to  quickly  and  reliably  verify  which  third-country  bidders  have  legally 
guaranteed  access  to  bid  for  an  intended  procurement,  procuring  authorities  and  procuring 

4  

5  
6  

Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying 
down the Union Customs Code (OJ L 269, 10.10.2013, p. 1). 
https://trade.ec.europa.eu/access-to-markets/en/contact-form?type=COMPL_IPI. 
https://trade.ec.europa.eu/access-to-markets/en/form-assets/IPI_interested_parties_guidance.pdf. 

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entities can use the “Procurement4Buyers” tool7 that has been made available on DG Trade’s 
“Acces2Markets” website. It suffices to indicate the identity of the procuring entity, the subject 
matter  and  estimated  value  of  the  intended  procurement  (CPV  code8)  and,  where  required, 
answer some follow-up questions. The tool will then provide the user with a positive list of 
countries whose bidders are entitled to participate in the procurement, as well as a negative list 
of  countries  whose  companies  are  excluded  from  bidding.  The  latter  list  will  reflect  the 
outcomes of IPI decision making procedures.9 

2.  The IPI investigation concerning measures and practices of the PRC in the public 

procurement market for medical devices 

On 24 April 2024, the Commission launched, on its own initiative, an investigation pursuant 
to Article 5(1) of the IPI Regulation concerning measures and practices of the PRC resulting in 
a serious and recurrent impairment of access of Union economic operators, goods and services 
to the PRC’s public procurement market for medical devices. In accordance with Article 5(2) 
of the IPI Regulation, consultations with the PRC took place from 24 to 26 July 2024 in Beijing. 
The  consultations  did  not  lead  to  a  satisfactory  resolution  of  the  procurement  restrictions 
identified during the investigation.  

On 14 January 2025, upon conclusion of its investigation and the consultations with the PRC, 
the Commission made publicly available a report pursuant to Article 5(4) of the IPI Regulation 
containing the findings of its investigation and a proposed course of action10 (‘the investigation 
report’). The Commission presented the investigation report to the European Parliament and to 
the  Council,  pursuant  to  Article  5(4)  of  the  IPI  Regulation,  on  29  and  30  January  2025, 
respectively. 

This investigation was particularly challenging due to the opaque nature of the Chinese public 
procurement market. Discrimination against foreign suppliers does not stem solely from legal 
provisions,  but  also  from  a  plethora  of  administrative  measures,  internal  guidelines,  and 
instructions issued at various levels of government. A major difficulty was the collection of a 
large sample of procurement contracts from  the PRC in a format that allowed a meaningful 
assessment  of  the  existence  of  restrictive  measures  affecting  Union  companies  in  the 
accompanying documentation and tender conditions. These obstacles required the deployment 
of  very  substantive  resources.  Through  extensive  analytical  effort  and  cooperation  with 
stakeholders, the Commission was ultimately able to overcome these challenges and build a 
detailed picture of the systemic barriers in place. 

In  the  investigation  report,  the  Commission  concluded  that  the  PRC  has  established  a 
comprehensive system that systematically favours domestic medical devices over foreign ones 

https://trade.ec.europa.eu/access-to-markets/en/contact-form?type=COMPL_IPI. 

7  
8   Regulation (EC) No 2195/2002 of the European Parliament and of the Council of 5 November 2002 on the 

Common Procurement Vocabulary (CPV), as amended (OJ L 340 16.12.2002, p. 1; ELI: 
http://data.europa.eu/eli/reg/2002/2195/2022-07-10http://data.europa.eu/eli/reg/2002/2195/2022-07-10). 
https://webgate.ec.europa.eu/procurementbuyers/#/procumementlocation. 

9  
10   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 PRC in the public 
procurement market for medical devices, COM(2025) 5 and Commission Staff Working Document Factual 
findings of the IPI investigation on the procurement market for medical devices in the PRC  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 PRC 
in the public procurement market for medical devices, SWD(2025) 2 (‘the SWD’). 

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through  legally  binding  provisions  that  require  public  entities  to  prefer  domestic  products 
whenever a local alternative is available, reinforced by burdensome approval procedures for 
imported goods and sector-specific measures and target quotas for hospitals to acquire domestic 
products.  This  comprehensive  discriminatory  system  applies  to  all  categories  of  medical 
devices  and  in  the  entire  territory  of  the  PRC,  irrespective  of  the  value  of  the  procurement 
contracts concerned. In addition, the Commission found that the organisation of volume-based 
procurement  in  the  PRC  incentivizes  suppliers  to  offer  extremely  low  prices  to  win  large 
contracts and de facto excludes profit-oriented companies that do not receive State subsidies. 
The Commission found evidence of discriminatory and exclusionary practices in 87% of the 
procurement contracts it managed to examine. The Commission concluded that these measures 
and  practices  result  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. Therefore, they constitute third-country measures or practices within the 
meaning  of  Article  2(1),  point  (i)  of  the  IPI  Regulation.  Regarding  the  outcome  of  the 
consultations, the investigation report mentions that the Government of China (‘GOC’) claimed 
it would not open unilaterally its procurement market in relation to medical devices and did not 
propose specific corrective actions to remedy this serious and recurrent impairment of access.  

On  that  basis,  the  Commission  assessed  the  conditions  laid  down  in  Article  6  of  the  IPI 
Regulation in view of adopting an IPI measure as defined in Article 2(1), point (j) of the IPI 
Regulation. The Commission assessment focused on (i) the proportionality and adequacy of a 
possible IPI measure with regard to the identified measures and practices; (ii) the availability 
of alternative sources of supply; and (iii) the Union interest (the economic interest of the Union 
producers; the possible impact on Union contracting authorities and contracting entities, and 
the overall effects of the IPI measure on the Union economy). 

Following this assessment, the Commission  envisaged  to impose an IPI measure in the form 
of  exclusion  of  tenders  submitted  by  all  economic  operators  originating  in  the  PRC  for  all 
public  procurement  procedures  in  the  Union  having  as  subject-matter  the  procurement  of 
medical devices falling under the Common Procurement Vocabulary (‘CPV codes 33100000-1 
to 33199000-1 as defined in Regulation (EC) No 2195/200211) and with an estimated value 
equal to or above EUR 5 000 000 net of VAT. This is the most comprehensive measure that the 
Union can impose in the medical devices sector under the framework of the IPI Regulation, 
which  does  not  allow  measures  that  would  apply  to  procurement  procedures  with  a  lower 
estimated value. However, its scope remains narrower than that of the discriminatory measures 
and practices  identified in  the PRC. While the Chinese system  applies broadly  to  all public 
procurement contracts, regardless of the value, the IPI measure only targets contracts with an 
estimated value above 5 million euro. Moreover, the IPI measure allows successful bidders to 
source up to 50% of the medical devices used in fulfilling contracts from the PRC, thereby still 
enabling a substantial presence of Chinese-origin medical devices in the Union procurement 
markets. These limitations are a direct consequence of the thresholds and conditions embedded 
in the IPI Regulation itself.  

On  19  June  2025,  the  Commission  adopted  the  IPI  measure  by  means  of  a  Commission 
Implementing  Regulation  (EU)  2025/1197  of  19  June  202512  in  accordance  with  the 

11   Regulation (EC) No 2195/2002 of the European Parliament and of the Council of 5 November 2002 on the 
Common  Procurement  Vocabulary  (CPV),  as  amended  (OJ  L  340  16.12.2002,  p.  1;  ELI: 
http://data.europa.eu/eli/reg/2002/2195/2022-07-10http://data.europa.eu/eli/reg/2002/2195/2022-07-10). 
12   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 PRC to the European Union public procurement market for medical devices pursuant to 

4 

 
 
 
examination procedure referred to in Article 11(2) of the IPI Regulation in the Trade Barriers 
Committee. The measure entered into force ten days following its publication in the Official 
Journal  for  a  duration  of  5  years.  On  6  July  2025,  the  GOC  adopted  retaliatory  measures 
regarding EU companies, goods and services. 

Despite the efforts of the Commission to achieve improved market access for Union economic 
operators  and  Union-made  medical  devices  to  the  PRC’s  public  procurement  market  for 
medical devices, and numerous exchanges with the GOC, this IPI process has not yet resulted 
in the removal by the GOC of the identified measures and practices. The consultations with the 
GOC were however useful to better understand the restrictive measures and practices in the 
PRC and to identify the measures needed for their entire removal. The Commission remains 
committed to  continued  engagement with  the GOC, which  can continue until  the identified 
measures  and  practices  are  removed.  In  this  respect,  Article  6(10)  of  the  IPI  Regulation 
provides for the possibility for the Commission to suspend or withdraw an IPI measure if the 
third  country  concerned  takes  satisfactory  corrective  actions  to  eliminate  or  remedy  the 
impairment of access for Union economic operators, goods or services to public procurement 
or concession markets of that third country, thereby improving such access. The Commission 
will ensure close monitoring of the application of the IPI measure by EU contracting authorities 
and contracting entities including the exceptions to the application of the IPI measure. In this 
respect,  the  Commission  reserves  its  faculty  to  request  information  from  Member  States  in 
accordance with Article 13(1) of the IPI Regulation. 

3.  Insights drawn from the application of the IPI Regulation  

During  the  period  under  review,  the  Commission  has  gathered  information  on  alleged 
restrictive measures and practices in third countries using its own investigative resources and 
through contacts  with  the Union industry representatives in  different  sectors. The identified 
restrictions  typically  range  from  the  exclusion  of  Union  economic  operators  and/or  goods 
and/or  services  from  the  procurement  procedures  to  localisation  requirements  and  domestic 
preferences such as offsets, often resulting in the de facto exclusion.    

The Commission has gathered information which suggests that some of these measures and 
practices might strongly impair the Union industry access to third-country public procurement 
markets and result in lost opportunities for Union economic operators.    

Despite the indication of this significant economic prejudice, the Union industry has not made 
use of the possibility to submit a formal IPI complaint in accordance with Article 5(1) of the 
IPI Regulation regarding any of the measures or practices identified. The only IPI investigation 
during  the  reporting  period  was  thus  launched  ex-officio.  The  Commission  considers  that 
multiple factors may explain the absence of formal IPI complaints. 

First, in public procurement markets, active economic operators (bidders) often have a strong 
dependency  vis-à-vis  the  buyer  (the  public  authority). Although  the  Commission  has  put  in 
place  a  strict  confidentiality  policy  based  on  the  highest  standards  for  the  protection  of 
confidential information in handling complaints, economic operators across different sectors 
and active in different third country markets report a fear of suffering targeted retaliation and 
adverse treatment from the third country concerned in case of submitting a formal complaint.    

the 
Regulation 
http://data.europa.eu/eli/reg_impl/2025/1197/oj. 

2022/1031 

(EU) 

of 

European 

Parliament 

and 

of 

the  Council. 

5 

 
 
 
 
 
 
 
Second, EU companies currently active in third countries procurement markets have, on some 
occasions,  limited  interest  in  closing  the  Union  market  to  obtain  leverage  and  engage  in 
discussions with the country concerned. The assessment of the general interest when deciding 
on  the  initiation  of  an  investigation  needs  to  be  well  calibrated,  taking  into  account  the 
economic interest of all Union companies. 

To support the effective use of the IPI Regulation, the Commission has developed tools and 
guidance to facilitate its application by stakeholders across all sectors, as appropriate.  

The investigation concerning  measures  and practices of the PRC in  the public procurement 
market for medical devices was based on solid evidence. It has nonetheless highlighted certain 
gaps with regard to the data available regarding international public procurement flows. These 
shortcomings concern the difficulty in accessing the public procurement contract data needed 
to assess the participation of Union bidders in the public procurement of third countries, as well 
as the impact of existing third-country procurement barriers against Union bidders. There are 
also certain data gaps in the Union procurement market that render the assessment of impact 
of potential IPI measure(s) in the Union rather difficult. For instance, the current data on public 
procurement contracts available in the Tender Electronic Daily (‘TED’) indicates the origin of 
the successful bidder but does not provide information regarding the origin of the goods and 
services procured. There is also limited information about the subcontracting to third-country 
operators and the ultimate ownership of successful bidders. Enriching the TED database with 
such information, in particular the origin of the goods and services procured, would facilitate 
both the conduct of IPI investigations and the implementation and ex-post monitoring of IPI 
measures. 

4.  Conclusions 

In line with the legal requirements contained in the IPI Regulation, the Commission has put in 
place  the  tools  necessary  to  facilitate  the  application  of  the  IPI  Regulation  by  economic 
operators  and  contracting  authorities  and  entities.  The  report  on  the  application  of  the  IPI 
Regulation is also based on the Commission’s experience of the only IPI investigation so far, 
concerning measures and practices of the PRC in the public procurement market for medical 
devices.  

Regarding the longer-term outcome of this first investigation and the first IPI measures, it is 
premature to draw conclusions as to the extent to which the instrument has met the objective 
to open public procurement market in third countries. IPI measures serves as a leverage for the 
Union  to  obtain  such  opening.  Indeed,  although  a  satisfactory  solution  has  not  been  found 
during the consultation process with the GOC, the Commission remains open for engagement 
even after the imposition of the IPI measure, which could be suspended or withdrawn if the 
identified measures and practices are removed by the PRC.  

Finally,  it  is  important  to  note  that  the  Commission  gathers  extensive  information  on 
procurement  barriers  in  third  countries,  but  the  decision  to  launch  an  investigation  requires 
careful  consideration,  due  to  the  inherent  difficulties  in  navigating  foreign  procurement 
systems.  These  challenges  include  interpreting  complex  legal  frameworks,  identifying 
discriminatory  practices  that  may  not  result  from  legal  provisions  but  from  administrative 
measures  and  practices,  and  understanding  how  such  systems  apply  in  practice. This  often 
involves reviewing a large volume of procurement contracts, which are frequently not publicly 
available, or lack the necessary documentation for proper assessment. Close cooperation with 
industry on the ground is therefore essential. Maintaining open channels of communication, 

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and  ensuring  full  confidentiality  of  exchanges,  is  critical,  something  the  Commission  has 
already secured and continues to prioritise. 

7