EU Public Tenders and Chinese-Origin Medical Devices: The €5 Million Rule

What does the €5 million IPI rule actually prohibit in an EU tender?

When European procurement teams and medical device distributors discuss the European Union's International Procurement Instrument (IPI) restrictions on Chinese medical devices, headlines frequently flatten the legal reality into a blanket "ban." On 24 September 2026, that framing is legally and commercially incorrect. Commission Implementing Regulation (EU) 2025/1197 ¹, adopted on 19 June 2025 and entered into force on 30 June 2025, establishes an exact monetary threshold and a composition ceiling—not a market ban.

The measure represents the first time the European Commission has exercised its powers under Regulation (EU) 2022/1031 (the IPI Regulation) ². It followed an ex officio investigation initiated on 24 April 2024 into Chinese public procurement practices for medical devices ³. In its report published on 14 January 2025 (COM(2025)5 and SWD(2025)2) ³, and restated in Recital 19 of the implementing regulation, the Commission found that 87% of an examined sample of 35,504 Chinese public tenders with usable documents contained explicit or implicit prohibitions on imported medical devices or discriminatory requirements affecting that procurement. Volume-based procurement was a separate finding in the same investigation, not a subset of that 87% figure. Member states voted in favor of the measure on 2 June 2025 ¹⁰, and the Commission formally published the implementing regulation on 20 June 2025 ¹.

To understand what the regulation prohibits in practice, a distributor or hospital procurement officer must examine Article 1(1) of Implementing Regulation (EU) 2025/1197 ¹. The operative rule contains three strict cumulative criteria:

1. Procurement scope: The parent IPI Regulation applies to procedures under Directive 2014/23/EU (concessions), Directive 2014/24/EU (public procurement) and Directive 2014/25/EU (utilities). Defence procurement under Directive 2009/81/EC is outside that scope, as is procurement by the EU institutions under the Financial Regulation.
2. Product Code Scope: It applies exclusively to medical devices falling under Common Procurement Vocabulary (CPV) codes from 33100000-1 to 33199000-1.
3. Monetary Threshold Gate: It applies solely to procedures where the estimated total value of the contract, net of VAT, is €5,000,000 or more.

Where all three criteria are met, the regulation imposes a mandatory exclusion of tenders submitted by economic operators originating in the People's Republic of China (PRC) ¹. It does not disqualify European distributors bidding on those same tenders, provided the goods they supply conform to the composition limits set out in Article 2 ¹.

Crucially, the economic scope of the measure was calibrated by the Commission to remain proportionate. Recital 34, using Tenders Electronic Daily for 2017–2022, states that around 96% of registered Union medical-device procedures were below €5,000,000 and represented around 41% of the aggregated value of procedures in that database. Recitals 23 and 48 put the procedures at or above the threshold at around 59% of that same registered procurement value. Those shares are not shares of the entire EU medical-device market, public and private together. Recital 41 records industry data that public procurement is only 50% to 70% of Union medical-device consumption. A separate Reuters report, citing an EU official and MedTech Europe figures, described covered contracts as worth €60 billion or more a year inside a market of roughly €150 billion; that figure is press reporting, not a number in the regulation.

Furthermore, the IPI measure has zero application to private healthcare procurement. Private hospital networks, independent clinics, day-surgery centers, and commercial medical supply houses purchasing outside EU public procurement directives are completely exempt. For these private buyers, Chinese-origin medical devices face no procurement restrictions whatsoever, and operate strictly under standard CE certification, MDR conformity, and customs import requirements—the EU-side parallel to how the line-level US duty stack for a China-origin single-use order governs customs entry without touching domestic sales channels.

Are you excluded because your company is Chinese, or because your devices are?

The single most common operational error made by tender desks and distributor sales teams is confusing the origin of the bidder (the economic operator) with the origin of the goods (the medical devices). Implementing Regulation (EU) 2025/1197 ¹ maintains a rigorous legal separation between these two concepts, referencing two entirely separate bodies of EU law in Article 2(2)(a).

Economic Operator Origin (The Bidder): Under Article 2(2)(a) of the implementing regulation, the origin of an economic operator is determined in accordance with Article 3 of Regulation (EU) 2022/1031 ². For legal persons, the test is two-pronged:

• Incorporation and Substantive Operations: A company originates in the country under whose laws it is incorporated or organized, provided it maintains substantive business operations in that country.
• Dominant Influence: If a company is incorporated in an EU member state or a third country but lacks substantive business operations there, its origin follows the country of the natural or legal persons who exercise a dominant influence over it (by ownership, financial participation, or corporate control rules).

This rule means that a manufacturer incorporated in China (such as Weihai Medison Medical Equipment Co., Ltd.) is an economic operator originating in the PRC and cannot submit a tender as a prime contractor in an EU public procedure valued at €5,000,000 or more ¹. It also means that establishing a shell entity or mailbox office within the EU without substantive commercial operations, local payroll, and independent management does not confer EU operator origin ¹¹.

However, if an independent European medical distributor, wholesaler, or logistics group incorporated in Germany, France, Italy, or Spain submits the tender, that distributor is an EU economic operator. Its bid cannot be excluded under Article 1(1) ¹. The distributor is fully eligible to participate in the tender, regardless of whether the tender value exceeds €5,000,000.

Medical Device Origin (The Goods): Once an eligible non-Chinese operator submits a tender, the analysis shifts to the origin of the products offered. Article 2(2)(a) explicitly directs contracting authorities to determine the origin of medical devices in accordance with Article 60 of Regulation (EU) No 952/2013 (the Union Customs Code, or UCC) ⁷. Article 60 sets out the Union's non-preferential origin rules: goods wholly obtained in a single country originate there; goods produced in more than one country originate in the country where they underwent their last, substantial, economically justified processing or working, in an undertaking equipped for that purpose, resulting in the manufacture of a new product or representing an important stage of manufacture ⁷.

For sterile single-use medical consumables—such as circumcision staplers, negative pressure wound therapy (NPWT) dressings, or sterile hypodermic injection needles—the country of non-preferential origin is typically the country where component molding, precision assembly, packaging, and terminal sterilization (ETO or gamma irradiation) occur. If a device is manufactured and sterilized in Weihai, China, its non-preferential origin is China under Article 60 UCC ⁷.

Article 2(1) of Implementing Regulation (EU) 2025/1197 ¹ then connects this goods origin to the successful tenderer's contract obligations by invoking Article 8 of Regulation (EU) 2022/1031 ². Successful non-Chinese bidders are bound by two strict 50% caps throughout the entire contract execution period ⁹:

1. The Goods Ceiling: The tenderer may not supply medical devices originating in the PRC representing more than 50% of the total value of the contract.
2. The Subcontracting Ceiling: The tenderer may not subcontract more than 50% of the total value of the contract to economic operators originating in the PRC.

Two further rules in Regulation (EU) 2022/1031 are easy to over-read from secondary summaries. Article 3(2) states that where a Chinese-origin person or entity participates in a group and that participation is less than 15% of the tender value, the IPI measure does not apply to that tender, unless those persons or entities are necessary to fulfil the majority of at least one selection criterion. Separately, Article 7 lets the Commission, on a justified Member State request, list local contracting authorities in administrative units below 50,000 inhabitants that are exempt. That list is not automatic, lasts three years, and may be granted only if authorities that remain covered still account for more than 80% of the Member State's above-threshold contract value. ²

How is the threshold calculated for frameworks, options, renewals and lots?

A distributor might review an invitation to tender from a regional hospital procurement consortium with an annual estimated budget of €1,500,000 and conclude that the €5,000,000 IPI threshold does not apply. In many cases, that conclusion is a costly miscalculation. Article 2(2)(b) of Implementing Regulation (EU) 2025/1197 ¹ explicitly states that the calculation of the estimated contract value must follow the rules laid down in Article 5 of Directive 2014/24/EU ⁶.

Article 5 of Directive 2014/24/EU establishes four specific calculation principles that frequently pull consumable contracts into covered IPI territory ⁶, ¹²:

1. Total Amount Payable Net of VAT: The calculation is based on the total amount payable, estimated by the contracting authority, excluding VAT, at the moment the procurement notice is dispatched.
2. Inclusion of Options and Renewals (Article 5(1)): The calculation must explicitly take into account the maximum total amount payable, including any form of option and any renewals of the contracts.
3. Framework Agreements and Dynamic Purchasing Systems (Article 5(5)): For framework agreements and dynamic purchasing systems (DPS), the value to be taken into account is the maximum estimated value net of VAT of all the contracts envisaged for the total term of the framework agreement or system.
4. Aggregation of separate supply lots (Article 5(9) of Directive 2014/24/EU, not Article 5(8), which covers works and services): the value of all lots for similar supplies is aggregated. Article 5(10) lets an authority waive lots below €80,000 for supplies if the waived lots together do not exceed 20% of the aggregate. Article 6(5) of Regulation (EU) 2022/1031 then says the IPI measure does not apply to those waived lots.

Consider a concrete European hospital consumables framework: A regional healthcare authority tenders a 4-year framework agreement for single-use surgical and wound-care consumables. The baseline call-off is estimated at €1,300,000 per year, with an optional 1-year extension and a 15% contingency option for sudden surge volume. Under Directive 2014/24/EU Article 5 ⁶, the contracting authority does not assess €1,300,000. It calculates the maximum lifetime commitment: (4 years × €1.3M) + (1 optional year × €1.3M) + 15% upside = €5,200,000 + €1,300,000 + €975,000 = €7,475,000 net of VAT. This framework agreement is squarely in scope of Implementing Regulation (EU) 2025/1197 ¹.

Similarly, in multi-lot tenders, if a hospital group tenders surgical consumables across four lots—Lot 1 (surgical staplers, €2.2M), Lot 2 (wound dressings, €1.8M), Lot 3 (hypodermic needles and syringes, €1.2M), and Lot 4 (catheters, €900k)—the aggregated value is €6,100,000. Because the aggregated procedure exceeds €5,000,000, and none of these illustrative lots is below the €80,000 supply waiver, the IPI measure engages for each lot. A distributor bidding only on Lot 3 (€1.2 million) still has to meet the bidder and 50% rules.

How does the 50 percent cap work in a mixed single-use basket?

Because EU-domiciled distributors can bid on covered tenders, the critical operational challenge is structuring a compliant product basket. Under Article 2(1) of Implementing Regulation (EU) 2025/1197 ¹, a winning bidder is legally bound to ensure that Chinese-origin devices do not exceed 50% of the total contract value throughout the entire life of the contract.

The scope of affected medical devices is defined by CPV codes 33100000-1 to 33199000-1 (Medical equipments). Under Regulation (EC) No 2195/2002 on the Common Procurement Vocabulary, this range encompasses virtually all medical devices and consumables utilized in clinical settings, including:

• CPV 33140000-3: Medical consumables (the overarching category for disposables)
• CPV 33141110-4: Dressings (gauze, hydrocolloids, foam, and wound contact layers)
• CPV 33141200-2: Catheters (drainage, vascular, and urinary catheter lines)
• CPV 33141320-9: Medical needles (hypodermic, biopsy, and injection needles)
• CPV 33141310-6: Syringes (33141300-3 is the parent class for venepuncture and blood-sampling devices, not the syringe code itself)
• CPV 33162200-5: Operating-theatre instruments (disposable surgical staplers, trocars, and cutting tools)
• CPV 33169000-2: Surgical instruments (general surgical and wound-closure disposables)

To demonstrate how an EU distributor structures a winning bid that incorporates Chinese-origin sterile consumables without violating the 50% ceiling, consider a real-world €6,000,000 4-year regional tender covering urology, surgical consumables, and perioperative wound management. The distributor sources high-specification, cost-competitive disposables from Weihai Medison Medical Equipment Co., Ltd. (VEMERIX), paired with European-manufactured equipment and wound dressings:

In this model basket, Chinese-origin sterile single-use devices represent €2,700,000, or exactly 45.0% of the total contract award. The remaining 55.0% consists of European-origin capital pumps and specialized dressings. The tender satisfies Article 2(1) ¹ with a 5.0% safety buffer. This composition demonstrates that European distributors do not need to abandon reliable Chinese manufacturing partners; rather, they must deliberately engineer the basket composition at the bid desk.

Crucially, distributors must actively manage this 50% ratio during contract execution. If hospital call-off volumes shift during Year 2—for instance, if the hospital orders more circumcision staplers and fewer German-made vacuum pumps—the Chinese-origin share could theoretically drift above 50%. Under Article 2(1) of the implementing regulation and Article 8 of Regulation (EU) 2022/1031 ¹, ², the contractor is legally obligated to maintain compliance throughout the contract duration. Prudent distributors include clause language in their sub-distribution or hospital supply agreements stipulating that rebalancing of equivalent non-Chinese lines will occur if consumption patterns threaten statutory thresholds.

When can a contracting authority still buy Chinese-origin devices?

Even when a public procurement procedure exceeds €5,000,000 and involves products in the covered CPV range, the exclusion of Chinese bidders or the 50% cap on Chinese devices is not absolute. Article 9(1) of Regulation (EU) 2022/1031 (the parent IPI Regulation) ², reinforced by Recital 37 of Implementing Regulation (EU) 2025/1197 ¹ and the Commission's official press release ⁵, provides two critical statutory exception pathways:

1. No Alternative Suppliers (Technical Monopoly): Under Article 9(1)(a), a contracting authority may, on an exceptional basis, decide not to apply the measure where only tenders from economic operators originating in China meet the tender requirements. The article does not itself create a separate test that Chinese-origin devices are the only products that fit a specification.
2. Overriding Reasons Relating to the Public Interest: Under Article 9(1)(b), the authority may decide not to apply the measure for overriding reasons relating to the public interest, and the article gives public health and protection of the environment as examples. Recital 37 of the implementing regulation reads this pathway as also covering the case where only Chinese bidders can offer specific devices needed for those public-interest reasons.

The Commission's 20 June 2025 press release says exceptions exist where no alternative suppliers are available. That is an authority decision under Article 9. It is not a product category, including circumcision devices or other single-use lines, that automatically sits outside the measure.

However, applying an Article 9 exception is not an informal administrative shortcut. The authority records the ground and a detailed justification. Article 9(2) requires it to send the Commission, through the channel decided by the Member State and no later than 30 days after award, its identity, a description of the contract, the operators' origin, and the ground for not applying the measure. There is no Article 9(3) approval step ². Suppliers and distributors cannot claim an exception on their own initiative; the determination rests exclusively with the contracting authority.

What origin evidence belongs in the tender file?

Contracting authorities apply the measure and may ask for origin information during the procedure under Article 3(3) of Regulation (EU) 2022/1031. Article 8 does not prescribe a fixed five-document pack that every committee must demand before award. Article 8(1)(c) requires the successful tenderer to provide adequate evidence on request, at the latest when the contract has been performed. Article 8(2) says it is sufficient to show that more than 50% of the total contract value originates outside China. Article 8(1)(d) sets a charge of 10% to 30% of total contract value if the 50% goods or subcontracting obligation is not observed.

To ensure that a tender submission is fully defensible on award day, an EU distributor bidding single-use consumables must assemble a dedicated "Tender-File Origin Block." This block should be prepared alongside public tender specification evidence for single-use devices and remaining-shelf-life tender clauses for sterile devices. A practical origin block that usually survives that request has five parts. They are a working file, not a list the regulation names as mandatory:

1. Economic Operator Origin Declaration: A formal declaration executed by the prime contractor establishing its corporate domicile, registration details, tax residence, and operational substance in an EU member state under Article 3 of Regulation (EU) 2022/1031.
2. Per-SKU Non-Preferential Certificate of Origin (COO): An official Certificate of Origin issued by a competent chamber of commerce or customs authority in the manufacturing country, certifying the non-preferential origin of each product code under Article 60 of the Union Customs Code.
3. Tender Value Composition & Bill of Materials (BOM) Schedule: A line-by-line financial schedule of the tender offer, detailing the net price of each line item, its certified country of origin, and the aggregate percentage of Chinese-origin goods, demonstrating that the total remains strictly at or below 50.0%.
4. Subcontracting Allocation Schedule: A declaration confirming the corporate origin of all proposed subcontractors (logistics, sterilization, warehousing, maintenance) and demonstrating that subcontracting to Chinese-origin operators does not exceed 50.0% of the total contract value under Article 8(1)(a).
5. Conformity file for the SKUs offered: the declaration of conformity, and a notified-body certificate only where the device class requires one, plus the EUDAMED actor registration the manufacturer actually holds. Do not treat a portfolio-wide MDR certificate as proven.

What could change before 27 November 2026 — and before mid-2030?

International trade regulation in the medical technology sector is dynamic. Commercial teams cannot treat Implementing Regulation (EU) 2025/1197 as a static instrument. On 24 September 2026, three distinct regulatory clocks govern the future trajectory of the measure ¹, ⁴, ⁹:

Clock 1: The First IPI Review Consultation (Closing 27 November 2026): On 10 September 2026, the European Commission's Directorate-General for Trade and Economic Security officially launched the public consultation for the first formal review of the International Procurement Instrument ⁴. Mandated by Article 14 of Regulation (EU) 2022/1031 ², the review evaluates how contracting authorities and economic operators have applied the regulation and the medical-devices measure in practice. The consultation runs from 4 September to 27 November 2026 ⁴. Stakeholder feedback on tender administrative burdens, availability of substitute devices, and the functioning of the €5 million threshold will directly inform the Commission's report to the European Parliament and Council. Distributors and healthcare organizations have until 27 November 2026 to submit empirical operational data.

Clock 2: Five-year expiry under Article 6(11): An IPI measure expires five years from its entry into force. Implementing Regulation (EU) 2025/1197 entered into force on 30 June 2025, so the statutory term runs to 29 June 2030 on the day-count used in law-firm analyses. Article 6(11) requires the Commission to open a review no later than nine months before expiry. After that review it may extend the measure for five years, adjust it, or replace it. Article 6(8) is the provision that defines the scope of a measure. It is not the duration clause.

Clock 3: Early Suspension or Withdrawal Mechanism: The IPI framework is designed as a reciprocal leverage tool, not a permanent tariff wall. Article 6(10) of Regulation (EU) 2022/1031 allows the Commission to withdraw an IPI measure or suspend its application where it considers that the third country has taken satisfactory corrective action or has undertaken commitments to end the practice. The 20 June 2025 press release states the same suspension logic. Recital 48 of the implementing regulation is a different passage: it estimates that covered procedures are around 59% of TED-registered medical-device procurement value and discusses a possible import effect. It is not the suspension clause.

Reciprocal Context: China's Mirror Notice of July 2025: In response to the EU's 20 June 2025 adoption of Implementing Regulation 2025/1197, Chinese authorities introduced reciprocal restrictions. As documented in legal analyses by Sidley Austin and Hogan Lovells Cadwalader ⁹, ¹⁵, China's Ministry of Finance published a notice effective 6 July 2025 restricting the participation of EU-origin medical devices in Chinese government procurement for projects exceeding RMB 45 million (approximately €5.7 million). The Chinese measure similarly established a mirror 50% cap on EU-origin components and exempted procedures where only EU-origin devices could satisfy technical requirements. Law-firm observers note that because few municipal Chinese hospital tenders exceed RMB 45 million, the practical impact within China has been limited, serving primarily as a reciprocal diplomatic counterweight ¹⁵.

Where VEMERIX fits — and where due diligence still begins

Understanding cross-border procurement rules requires transparent alignment between manufacturer capability and distributor responsibilities. VEMERIX operates under clear, verified commercial and regulatory parameters:

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.

As a manufacturer based in Weihai, Shandong Province, China, Weihai Medison Medical Equipment Co., Ltd. is an economic operator originating in the PRC under Article 3 of Regulation (EU) 2022/1031 ². VEMERIX does not bid directly as a prime contractor on European public tenders, does not claim an exemption from the IPI framework, and does not provide legal or customs brokerage services. In covered public tenders exceeding €5,000,000 net of VAT, VEMERIX products are subject to the 50% basket composition cap when bid by independent European distributors.

What VEMERIX provides to its international distribution partners is complete, rigorous evidentiary support to ensure that their tender files withstand strict contracting authority audit:

• Manufacturing-origin records for each SKU: the factory documents a chamber of commerce or customs authority would need before it issues a non-preferential certificate of origin. VEMERIX does not itself issue that official certificate.
• Current conformity files, requested per SKU: the public circumcision device page records CE. The public pages for the NPWT drainage dressing and the sterile injection needle do not state an EU MDR certificate. A tender file should use the certificate and declaration that match the SKU being offered, not a portfolio-wide MDR claim.
• Quality records the distributor should request per lot: the circumcision device page records ethylene-oxide sterilization. Sterilization validation, biocompatibility, and remaining shelf life should be checked against the lot file and against remaining-shelf-life tender clauses for sterile devices, rather than assumed from a brand-level statement.
• Value split at the bid desk: the 50% test uses the tenderer's contract prices and call-off pattern, not a factory ex-works sheet. The distributor builds that schedule from its own offer.

Due diligence begins with the distributor's tender desk. Distributors bidding on public healthcare contracts must calculate the total lifetime value under Article 5 of Directive 2014/24/EU, review tender-specific origin requirements with the contracting authority, and seek counsel from qualified public procurement attorneys. Where distributors require registration support for international market expansion, VEMERIX coordinates technical evidence packets aligned with our circumcision device registration evidence pack guide and our lot-by-lot NPWT tender and RFQ specification. For technical packs, CE documentation, and sample evaluation requests, contact our international team through quality documentation, downloads, or our contact portal.

Frequently asked questions

Can we still sell Chinese-origin consumables in EU public tenders at all?

Yes. Chinese-origin consumables are not banned from EU public tenders. In procedures with an estimated contract value below €5,000,000 net of VAT, the measure does not apply. In the Commission's TED extract for 2017–2022, that band was about 96% of registered medical-device procedures. Chinese-origin devices can be bid in those procedures without the IPI restriction. In procedures valued at €5,000,000 or more, an EU-domiciled distributor can still supply Chinese-origin devices, provided they do not exceed 50% of the total contract value. Furthermore, direct Chinese bidders are excluded only in procedures at or above the €5,000,000 threshold.

Does the IPI measure apply to private hospital purchasing?

No. Commission Implementing Regulation (EU) 2025/1197 applies to public procurement and concession procedures covered by the IPI Regulation, which are those under Directives 2014/23/EU, 2014/24/EU and 2014/25/EU. Private hospital groups, private surgical centers, commercial clinics, and medical distributors purchasing for private commercial resale are completely exempt. In private purchasing, Chinese-origin devices face no procurement exclusion or composition caps.

Does the rule apply in the United Kingdom?

No. The International Procurement Instrument is an EU regulation and does not apply in the United Kingdom. NHS procurement in England, Scotland, Wales, and Northern Ireland is governed by UK procurement legislation (including the Procurement Act 2023 and the Provider Selection Regime for healthcare services). Chinese medical devices placed on the UK market operate under MHRA registration, UKCA/CE transitional recognition, and individual trust procurement standards, as detailed in our Great Britain market placement guide.

Our framework is worth €4 million a year for four years — is it in scope?

Yes, absolutely. Under Article 2(2)(b) of Implementing Regulation (EU) 2025/1197 and Article 5(5) of Directive 2014/24/EU, the estimated value of a framework agreement is the maximum estimated value net of VAT of all contracts envisaged for the total term. A framework agreement with an annual spend of €4,000,000 across a 4-year term has a total estimated contract value of €16,000,000. Because €16,000,000 substantially exceeds the €5,000,000 threshold, the tender is fully in scope. Direct Chinese bidders are excluded, and an EU distributor can supply Chinese-origin lines up to a maximum of €8,000,000 (50% of the total award).

What if the only device that meets the tender specification is Chinese?

Under Article 9(1)(a), the authority may on an exceptional basis not apply the measure where only tenders from Chinese-origin economic operators meet the tender requirements. Where the issue is that only Chinese-origin devices meet a public-interest need, Recital 37 points to the Article 9(1) exceptions, and Article 9(1)(b) is the public-interest ground, with public health given as an example. The authority justifies the decision and, under Article 9(2), informs the Commission no later than 30 days after award. The supplier cannot take that decision itself.

Did China respond with its own restrictions?

Yes. Following the EU's adoption of the IPI measure, China's Ministry of Finance implemented reciprocal restrictions effective 6 July 2025 on EU-origin medical devices in central government procurement projects exceeding RMB 45 million (approximately €5.7 million). The Chinese measure imposes a mirror 50% cap on EU-origin components and exempts tenders where only EU devices satisfy requirements. Because municipal hospital tenders in China rarely exceed RMB 45 million, legal analysts report that the practical commercial impact within China has been limited.

Is this the same instrument as the EU Foreign Subsidies Regulation cases?

No. The International Procurement Instrument (Regulation (EU) 2022/1031) and the Foreign Subsidies Regulation (FSR, Regulation (EU) 2022/2560) are completely distinct legal regimes. The IPI addresses reciprocal market access and imposes sector-specific measures based on third-country procurement discrimination (such as the €5 million medical device rule). The FSR addresses distortions in the internal market caused by foreign financial contributions. In public procurement, the Commission's notification procedure applies where the estimated contract value is at least €250 million and the bid involves a foreign financial contribution of at least €4 million per third country over the previous three years. The Commission can also ask for a notification below those thresholds. ¹⁶ The two instruments have different thresholds, legal triggers, and investigatory procedures.

When could the IPI measure be lifted or extended?

The measure can be suspended or withdrawn at any time if China takes concrete, verifiable steps to eliminate procurement discrimination against EU medical device manufacturers. If no settlement is reached, the measure expires five years after entry into force under Article 6(11) of Regulation (EU) 2022/1031, which law-firm day counts place at 29 June 2030. The Commission must open the expiry review no later than nine months before that date and may then extend the measure for five years, adjust it, or replace it. In the near term, the Commission's public consultation closing 27 November 2026 will produce the first formal assessment of the measure's operational impact.