Medical devices from China may be offered in a tender covered by the International Procurement Instrument (IPI), but only up to 50% of the contract value. Bids from contractors originating in China are excluded, and the bid of any other contractor, including a Polish one, in which goods from China exceed this limit is subject to rejection. The measure covers contracts for medical devices with a value of at least EUR 5 million, calculated together with similar supplies planned by the contracting authority.

Below we explain how to calculate the value threshold and the 50% limit, whether small lots of a contract are excluded from the IPI, and until when the application of the measure can be challenged.

What is the IPI measure concerning medical devices from China?

The IPI measure was introduced by Commission Implementing Regulation (EU) 2025/1197 of 19 June 2025, issued on the basis of Regulation (EU) 2022/1031. It applies in procedures launched from 30 June 2025 for medical devices under CPV codes from 33100000-1 to 33199000-1 with an estimated value of at least EUR 5,000,000 excluding VAT (Article 1(1) of Regulation 2025/1197). At the exchange rate of PLN 4.31 applicable from 1 January 2026, this amounts to PLN 21,550,000.

The measure operates on two levels. First, it excludes bids from contractors originating in the People’s Republic of China. Second, every successful tenderer, regardless of origin, must meet the requirements of Article 8 of Regulation 2022/1031 (Article 2(1) of Regulation 2025/1197). It may not subcontract more than 50% of the total value of the contract to subcontractors from China, and during the term of the contract goods and services from China may account for no more than 50% of that value. On request, it must provide evidence, and for breaching the limits it pays a proportionate charge of 10% to 30% of the total value of the contract. The contracting authority must include these undertakings in the procurement documents. In a case concluded by KIO order of 19 December 2025, KIO 4911/25, a contractor alleged that the terms of the contract did not contain the undertaking concerning the 50% limit, and after the appeal was lodged the contracting authority annulled the rejection of its bid.

The origin of goods is determined according to the EU customs rules referred to in Article 3(4) of Regulation 2022/1031, and not according to the registered office of the manufacturer or distributor. The origin of a contractor depends on the state in which it was established and conducts substantial business activity, and in the absence thereof on the origin of the entities that control it. We write about other restrictions for contractors from outside the Union in the article on the amendment of the PPL concerning contractors from third countries.

When is a bid with medical devices from China subject to rejection?

A bid in which goods originating in China exceed 50% of the total value of the contract is subject to rejection as inconsistent with the terms of the contract (Article 226(1)(5) of the Public Procurement Law (PPL)). The limit applies to every contractor, including a Polish distributor of products manufactured in China. The Public Procurement Office (UZP), in its position of 3 September 2025, indicated that a contractor, regardless of origin, may not offer goods from China above this limit, “because in such a situation its bid will be subject to rejection as inconsistent with the terms of the contract (Article 226(1)(5) PPL)”.

If a separate contract is concluded for each lot of the procedure, the limit is, as a rule, calculated separately for each lot, on the basis of the price form and the declared country of origin of the items. For example, where the bid for a lot amounts to PLN 200,000 net and an item from China to PLN 116,000 net, the share of goods from China is 58% and the bid is inconsistent with the terms of the contract.

A general statement that the contractor will comply with the limit will not help, because the specific content of the bid is decisive: the products, prices and country of origin. After the time limit for submitting bids, it is also not possible to replace a product with one from another country, as this would be a change to the content of the bid prohibited by Article 223(1) PPL. We discuss similar limits on explanations in the article on the lack of the manufacturer and model in the price form.

Can a tender below EUR 5 million be covered by the IPI?

Yes. The EUR 5 million threshold refers to the contract value calculated in accordance with Article 5 of Directive 2014/24/EU (Article 2(2)(b) of Regulation 2025/1197), and not to the value of a single procedure. The contracting authority must therefore aggregate planned similar supplies, including those awarded in separate procedures (Article 30(1) and (2) PPL). The UZP, in its position of 28 July 2025, confirmed that this requirement concerns the value of the contract as a whole, not of its lots.

The key ruling is the KIO judgment of 12 March 2026, KIO 454/26. A university hospital applied the IPI in a tender for dressings, suture materials and other medical devices worth approx. EUR 4.13 million, because similar supplies planned for 2026 were worth approx. EUR 6.96 million in total. The Chamber dismissed the appeal of a contractor offering materials manufactured in China. It held that the contracting authority “was not so much entitled as obliged to aggregate the value of similar contracts”, and that relating the threshold to a single procedure “could lead to circumvention of the provisions, not only of the classic directive but also of the IPI regulation”. The Chamber considered sufficient the information from the answers to contractors’ questions, confirmed by a draft procurement plan which the hospital could not publish without an approved budget.

A dispute may, however, concern which supplies are “similar”. Recital 19 of Directive 2014/24/EU links similarity with an identical or similar intended use of the products. The broader the group of aggregated devices, the easier it is to challenge, which is why the contracting authority should document the similarity of the supplies and the fact that they were planned at the time the value was estimated.

Are lots of a contract below EUR 80,000 excluded from the IPI?

Not automatically. Article 6(5) of Regulation 2022/1031 excludes the IPI only for lots that are to be awarded in accordance with Article 5(10) of Directive 2014/24/EU. In the PPL, this corresponds to Article 30(4), which allows a lot to be awarded under the provisions appropriate to its value if it is less than EUR 80,000 for supplies and services (PLN 344,800 in 2026), and the aggregate value of such lots does not exceed 20% of the contract value. This is an entitlement, not an obligation of the contracting authority, and the decision to use it is made before the procedure is launched.

Therefore, if all lots are conducted in a single tender under EU provisions, the IPI covers each of them, even a lot worth a few tens of thousands of zlotys. In our view, this is also how the UZP position of 28 July 2025 should be read, according to which the IPI measure “does not apply to contracts for individual lots whose value is less than the PLN equivalent of EUR 80,000 for supplies or services”, provided that the 20% limit is maintained. We have not yet found a KIO ruling that would resolve this issue on the merits.

Until when can the application of the IPI be challenged?

The application of the IPI must be challenged by an appeal against the contract notice or the terms of reference (SWZ). In EU-threshold contracts, the time limit is 10 days from the publication of the notice in the Official Journal of the EU (OJEU) or the posting of the procurement documents on the website (Article 515(2)(1) PPL). After that, the provisions on the IPI and the 50% limit are binding on all contractors.

Pleas raised only in an appeal against the rejection of a bid are belated. In its judgment of 9 October 2025, KIO 3671/25, the Chamber rejected the appeal in the part challenging the procurement documents (Article 528(3) PPL) and indicated that such pleas do not cause the time limit for challenging the description of the subject matter of the contract to “be restored”. The case did not concern the IPI, but the thesis is of a general nature.

The correct approach is shown by case KIO 454/26. The contractor first asked questions about the contract value and then challenged the SWZ within the time limit, thanks to which the Chamber examined the estimation on the merits. It lost, however, the plea concerning failure to make documents available, because it did not request the procedure record as a specific document, even though it is public (Article 74(1) PPL). We write more about preparing an appeal in the article on how to write an effective appeal to KIO.

What to do in practice?

Most IPI disputes can be avoided at the stage of preparing the bid or the procurement documents. The contractor should remember the following steps:

1. Check whether the procedure is covered by the IPI – even if its value seems low;
2. Calculate the share of goods from China in each lot – and if it exceeds 50%, change the product range before the time limit for submitting bids;
3. Raise doubts in questions on the SWZ – concerning the contract value or the IPI covering small lots, and if necessary lodge an appeal within 10 days;
4. Monitor the limit throughout the term of the contract – also when supplying substitute products.

The contracting authority, in turn, should take care of four issues:

1. Document the estimation of the value – including the plan of procedures and the similarity of the aggregated supplies;
2. Decide on small lots before launching the procedure – whether you will award any of them under Article 30(4) PPL;
3. Include the undertakings under Article 8(1) of Regulation 2022/1031 in the SWZ and the draft contract provisions – and also indicate the ground for exclusion in the contract notice (in case KIO 454/26 the contracting authority accepted the plea that the notice referred in this respect only to the ESPD);
4. Require the country of origin to be stated – for each item of the product range.

Summary

The IPI measure excludes bids from contractors from China, but for other contractors the key issue is the 50% limit of the contract value attributable to goods from China. A bid exceeding the limit is subject to rejection and cannot be remedied after the time limit for submitting bids. The EUR 5 million threshold is calculated together with similar supplies, so the IPI may also cover smaller tenders, and its application must be challenged immediately, within the time limit for an appeal against the SWZ.

Frequently asked questions

Can a Polish contractor offer medical devices from China in a tender covered by the IPI?

Yes, but goods originating in China may account for no more than 50% of the total value of the contract throughout the term of the contract. The exclusion applies only to bids from contractors originating in China.

How do you calculate the 50% limit for goods from China?

The net value of the items originating in China should be divided by the total net value of the contract; in a procedure divided into lots, as a rule separately for each lot. A result above 50% means that the bid is subject to rejection.

Can a bid that exceeds the 50% limit be corrected?

Not after the time limit for submitting bids. Replacing a product with one from another country would change the content of the bid, and a general statement of compliance with the limit does not remove the inconsistency resulting from the price form.

How is the origin of a medical device determined?

According to the EU rules of customs origin referred to in Article 3(4) of Regulation 2022/1031. The decisive factor is the country in which the goods were wholly obtained or underwent their last substantial processing, not the registered office of the manufacturer or distributor.

The above material is for information and educational purposes only – it does not constitute legal advice or an opinion on a specific case. Assessment of a specific factual situation requires individual analysis. The article does not refer to any pending case and is based solely on published rulings and positions. Legal status as at 7 October 2026: Commission Implementing Regulation (EU) 2025/1197, Regulation (EU) 2022/1031, in particular Articles 3, 6(5) and 8, and the Act of 11 September 2019 – Public Procurement Law (consolidated text: Journal of Laws of 2026, item 793), in particular Article 30(1), (2) and (4), Article 74(1), Article 223(1), Article 226(1)(5), Article 515(2)(1) and Article 528(3).

Dominik Styczyński – attorney-at-law (radca prawny), public procurement law expert representing contractors and contracting authorities before the National Appeals Chamber (KIO)