EU Reviews Its Procurement Instrument After the China Medical-Device Case

What did the Commission announce on 10 September 2026?

The European Commission launched the first review of the International Procurement Instrument on 10 September 2026. The consultation runs from 4 September to 27 November 2026 and expressly includes, among others, traders, importers, manufacturers and public contracting authorities.

The IPI is an EU instrument governing access to public procurement markets. The review does not mean that every import from China is now subject to a new customs or import rule. It examines how the existing instrument may be structured and applied in the future.

The Commission identifies several review areas: scope, rules of origin, thresholds, the form of possible measures, obligations for successful bidders and exemptions. For suppliers of Chinese medical devices, the immediate practical issue is the quality of their records. A supplier involved in an EU public tender should be able to document the product’s origin, the operator structure and the Chinese share of the goods.

What existing measure is being reviewed?

The existing IPI measure concerns the access of Chinese companies and Chinese medical devices to the EU public-procurement market. The Commission adopted that first measure on 19 June 2025.

The International Procurement Instrument is not a general import ban. It concerns public procurement and can restrict access by economic operators or goods from third countries to public tenders. This distinction matters to importers: a supplier may import goods for private buyers without the IPI review automatically creating a new general import obligation. A shipment intended for a public tender may nevertheless raise additional access and documentation questions.

The underlying EU regulation sets a EUR 5 million net threshold for goods. An IPI measure may affect no more than 50% of the contract value. These figures describe the framework established by the supplied facts. Whether the Commission changes that framework after the consultation remains open as of the event date.

Why are medical-device suppliers particularly relevant?

Medical-device suppliers should be able to explain the origin and corporate relationships connected with their products in an EU public tender. The reason is the Commission’s finding that 87% of the Chinese medical-device tenders it examined contained express or indirect prohibitions or discriminatory requirements against imported medical devices.

That figure concerns the Chinese tenders examined by the Commission. It does not mean that 87% of all Chinese medical devices are inadmissible or that 87% of all EU tenders are automatically restricted. It does explain why the EU is reviewing access to public procurement and why origin evidence is more than a formal side issue in this sector.

A supplier should not rely only on a label such as “Made in China” or “EU supplier” as an internal assessment when a tender examines economic origin or the composition of the goods. The supplied facts expressly identify three documentation areas: origin, operator structure and the Chinese share of the goods. The exact form of evidence may depend on the tender and applicable requirements; the consultation has not yet produced a final new evidence list.

What does the review mean for private importers?

The review does not, at this stage, change a general import rule for private importers. The supplied facts do not establish a general import ban on Chinese medical devices or a new general customs obligation as a result of the consultation.

Private importers should distinguish between two situations. In a purely private purchase, the general IPI review is not automatically the central issue. In a shipment intended for public procurement or an EU tender, the importer should assess whether the existing IPI measure and the specific tender conditions apply.

This distinction avoids two opposite mistakes. Treating every import from China as restricted because of the IPI would not be supported by the supplied facts. Ignoring the IPI issue for medical devices intended for a public authority would also be unsafe, because permission to physically import goods is not identical to eligibility for a public tender.

Which information should suppliers review now?

Suppliers should create a traceable file covering origin, operator structure and the Chinese share of the goods before entering an EU public tender. This is a prudent preparation step for public procurement, not a claim that the consultation has already introduced new binding evidence requirements.

1. Define the goods’ origin

Record where the goods are manufactured and which origin description the tender requires. Origin should not be described only through the seller’s registered location, because the supply chain may also involve manufacturing and the composition of the goods.

The supplied facts do not establish one universally applicable origin definition for every possible tender. An internal file should therefore distinguish the definition being used from the evidence supporting it. Unresolved issues should be identified rather than replaced with a blanket “EU” or “China” label.

2. Document the operator structure

Record the companies involved in manufacturing, distribution and the tender offer, together with their respective roles and operating relationships. Operator structure is a separate review area from the origin of the goods.

Calling a business an “EU importer” or “German trader” does not answer the entire question. Those terms describe a commercial role, not necessarily the full corporate or operating structure. For a tender, the participating economic operators and their functions should therefore be shown in a verifiable overview.

3. Track the Chinese share of the goods

Determine the Chinese share of the offered goods and retain the documents used for that assessment. The Chinese share is expressly one of the areas that suppliers of Chinese medical devices should document reliably for EU public tenders.

The supplied facts do not state one specific calculation method for that share. A company should therefore not present its own percentage as a universally binding EU method. Where the tender requests this information, a useful file separates individual components, their origins and the calculation logic applied.

4. Check contract value and procurement type

Check whether the buyer is conducting public procurement and whether the relevant value of the goods reaches the documented EUR 5 million net threshold. Under the underlying regulation, the threshold applies to goods.

The threshold alone does not determine every consequence. The importer must also assess whether a specific IPI measure applies and what conditions the tender sets. The established upper limit is that an IPI measure may affect no more than 50% of the contract value.

What remains open after the consultation?

The Commission has not yet communicated a final new rule for the period after the consultation. The open questions include scope, rules of origin, thresholds, the form of possible measures, obligations for successful bidders and exemptions.

These are substantive issues. A change in scope could determine which public-procurement procedures are covered. Different origin rules could change supply-chain documentation. New thresholds could expand or narrow the group of affected contracts. Additional obligations for successful bidders could make evidence requirements more specific after award.

The supplied facts do not show which options the Commission will adopt. Suppliers should therefore separate the existing framework from possible future changes. Internal procedures should not treat the consultation as an already adopted tightening of the rules.

Practical checklist for importers and suppliers

1. Classify the tender: Record whether the buyer is a public authority and whether the purchase falls within public procurement.
2. Check the value: Record whether the relevant goods value reaches or exceeds EUR 5 million net.
3. Map the supply chain: List the manufacturer, trader, importer and other economic operators, with each role clearly stated.
4. Support origin: Assess the goods’ origin using available records and flag unresolved points.
5. Document Chinese content: Record the Chinese share and the calculation applied, without claiming an unsupported universal calculation method.
6. Review the operator structure: Keep corporate and operating relationships separate from a simple sales or distribution label.
7. Compare tender documents: Check the tender’s specific requirements for origin, bidder obligations and possible exemptions.
8. Mark the legal status: Separate the existing IPI measure from the still-open outcome of the consultation.

What should importers do before 27 November 2026?

Importers should complete their public-procurement records and make unresolved origin questions visible before the consultation closes. The consultation ends on 27 November 2026.

The most reliable preparation is not to guess an unknown future rule. It is to organize the three documented areas—origin, operator structure and Chinese share of the goods—so that each relevant product can be assessed against the existing IPI measure. Importers should also record contract value, procurement type and the requirements of the specific tender.

The consultation expressly includes traders, importers, manufacturers and public contracting authorities. Organizations in these groups should review the published information and assess their exposure against the stated review areas. The supplied sources do not establish whether, or in what form, later changes will be adopted.

What is established and what remains uncertain?

It is established that the Commission has launched the first IPI review, that the consultation runs from 4 September to 27 November 2026, and that the existing measure concerns Chinese companies and Chinese medical devices in public procurement. The EUR 5 million net goods threshold, the 50% maximum share of contract value affected by an IPI measure and the finding concerning 87% of the Chinese medical-device tenders examined are also established by the supplied facts.

It is not established that the consultation has created a new general import rule. It is also not established which origin rules, thresholds, measures, bidder obligations or exemptions will apply after the review. Those points remain open until a further binding decision.

The practical consequence for importers is therefore clear: private imports should not be treated as identical to public procurement. Suppliers participating in EU tenders should nevertheless structure their origin, operator-structure and Chinese-content records now so that the existing IPI measure can be assessed.

Sources

• European Commission, Directorate-General for Trade and Economic Security: “Commission launches consultation on the first review of the International Procurement Instrument”, 10 September 2026.
• European Commission, Official Journal of the European Union: “Commission Implementing Regulation (EU) 2025/1197”, 20 June 2025.

Sources

Research checked on 2026-09-11. The following original sources support the factual claims:

• Europäische Kommission, Directorate-General for Trade and Economic Security – Commission launches consultation on the first review of the International Procurement Instrument (2026-09-10): Die Kommission startet die erste Überprüfung des IPI, nennt den Konsultationszeitraum vom 4. September bis 27. November 2026 und listet die betroffenen Prüffelder auf.
• Europäische Kommission, Amtsblatt der Europäischen Union – Commission Implementing Regulation (EU) 2025/1197 (2025-06-20): Die Verordnung beschränkt den Zugang chinesischer Wirtschaftsteilnehmer und Medizinprodukte zur EU-Beschaffung und dokumentiert die Schwelle von 5 Millionen Euro sowie die Begrenzung auf höchstens 50 Prozent des Auftragswerts.