Selling to EU hospitals through public tenders

Public hospitals in the EU buy under Directive 2014/24/EU once a contract reaches the EU thresholds. From 1 January 2026 to 31 December 2027, those are 140,000 euros for most supplies bought by central government authorities and 216,000 euros for supplies bought by sub-central authorities; which applies depends on whether the buyer is listed in Annex I as central government. A manufacturer from outside the EU can bid, but its standing depends on its country. Operators from countries covered by the WTO Government Procurement Agreement, or by another agreement binding the EU, must be treated no less favourably than EU operators. Operators from other countries have no right to equal treatment. The medical device rules apply separately, whatever the tender says.

Suppose a maker of diagnostic imaging accessories from outside the EU finds a supply tender from a regional health authority published on TED. The specification fits its product. Before the price, three questions decide whether the bid is worth writing: does the directive apply to this contract, does it apply to this bidder, and can the product be lawfully placed on the EU market at all?

Which purchases fall under the directive?

Directive 2014/24/EU applies to purchases by “contracting authorities”, which Article 2(1) defines as “the State, regional or local authorities, bodies governed by public law or associations formed by one or more such authorities or one or more such bodies governed by public law”. A bidder is an “economic operator”: any person or entity “which offers the execution of works and/or a work, the supply of products or the provision of services on the market”.

According to the European Commission, the threshold values that apply from 1 January 2026 to 31 December 2027, set by Commission Delegated Regulation (EU) 2025/2152, are:

Contract	Central government authorities	Sub-central authorities
Supplies and services	140,000 euros	216,000 euros
Social and other specific services (Annex XIV)	750,000 euros	750,000 euros
Works	5,404,000 euros	5,404,000 euros

Which column applies depends on the buyer. Under Article 2(1), central government authorities are “the contracting authorities listed in Annex I”, and sub-central contracting authorities are “all contracting authorities which are not central government authorities”.

One exception applies to the central-government figure. For supplies bought by contracting authorities operating in the field of defence, the 140,000 euro threshold covers only products listed in Annex III; for other products, the threshold is 216,000 euros.

European procurement notices are published on TED, Tenders Electronic Daily, the online Supplement to the Official Journal of the EU, which is free to search.

Can a manufacturer from outside the EU bid?

Article 25 of the directive sets the rule. Insofar as they are covered by the EU’s annexes to the GPA and by the other international agreements binding the Union, contracting authorities “shall accord to the works, supplies, services and economic operators of the signatories to those agreements treatment no less favourable than the treatment accorded to the works, supplies, services and economic operators of the Union.”

The Court of Justice drew the other side of that line in Case C-652/22, Kolin, on 22 October 2024. The case was decided under Directive 2014/25/EU, the utilities directive, not Directive 2014/24/EU, but it gives the Court’s reading of access for economic operators from countries without an agreement. Its press release summarises the ruling: economic operators from a third country that has not concluded an international agreement on public procurement with the EU “cannot rely on the provisions of the relevant directive” to claim participation “on the same footing as tenderers from Member States or third countries bound by such an agreement”. They also cannot rely on it to challenge an award.

That does not always shut them out. The Court held that, where no EU act exists on the point, “it is for the contracting entity to assess, on a case-by-case basis, whether economic operators from third countries which have not concluded an international agreement on public procurement with the European Union should be admitted”. A challenge by such an operator is examined under national law only.

The first question for a manufacturer from outside the EU is therefore not about the product. It is whether its country is party to the GPA or to a trade agreement with a procurement chapter covering the contract in question.

The medical device measure of 2025

The EU has also used its International Procurement Instrument for the first time, on medical devices. According to a law firm’s summary of Implementing Regulation (EU) 2025/1197, adopted on 19 June 2025 and effective from 30 June 2025, the measure excludes economic operators originating in China from EU public contracts for medical devices worth more than 5 million euros. It also caps at 50 percent both the share of the contract value that winning tenderers may subcontract to operators originating in China and the share of Chinese-origin medical devices they may supply. The measure runs for five years, renewable for five more, with limited exceptions that the contracting authority decides.

For a manufacturer outside China that sources components or finished devices there, the measure’s origin rules become part of any bid of that size.

Tender rules and device rules are separate

A tender decides who is awarded a contract. It does not decide whether a device may be sold in the EU. That is governed by Regulation (EU) 2017/745 on medical devices, and for a manufacturer from outside the EU it starts with Article 11(1): “Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.”

Conformity assessment, CE marking and the authorised representative are obligations of the manufacturer and the parties it appoints under the device rules. A tender that asks for CE-marked products asks for evidence of those, and winning the tender does not replace them.

What a hospital buyer asks about supply

Beyond the product and the price, tender documents can ask how the goods reach the hospital and what happens after delivery: where stock is held, the lead time to each delivery site, who is named on the import, how service and returns are handled, and how quickly a replacement arrives. For a bidder from outside the EU, each of those answers depends on where its stock sits. Distributors ask much the same, as set out in what European distributors ask before signing.

Payment is set by law as well as by contract. Under the Late Payment Directive, 2011/7/EU, public authorities pay within 30 days, which member states may extend to 60 days for public entities providing healthcare that are duly recognised for that purpose (Article 4(4)).

How this runs at EFC

EFC helps companies from outside the EU operate and grow in Europe. When a manufacturer bids, its answers on supply can rest on EFC’s operation: stock held in Portugal inside the EU, an importer of record on the customs import, and delivery to the buyer’s sites. Finding distributors that supply hospitals in a category is the work described on business development in Europe.

For medical devices, the customs import and the device rules are different things. Regulation (EU) 2017/745 gives importers their own duties in Article 13: they may place on the Union market only devices that conform, and they indicate their name and address on the device, its packaging or an accompanying document. Who carries the importer’s duties under Article 13 of Regulation (EU) 2017/745 is settled before the first shipment. EFC is not, by default, the device importer under that Regulation, does not act as an authorised representative, and does not handle conformity assessment; those stay with the manufacturer and the parties it appoints.

The tender documents govern

Each procedure is governed by its own tender documents and by the national law that transposes the directive, and whether a bidder’s country is covered by an agreement for a given contract depends on that agreement’s schedules. This article sets out the framework; it is not legal advice.

Sources

Label	Value	Source
Definitions	contracting authorities; economic operator	Directive 2014/24/EU, Article 2, EU text on legislation.gov.uk, opened 2026-08-21
Thresholds 2026 to 2027	1 January 2026 to 31 December 2027; Delegated Regulation (EU) 2025/2152; supplies and services 140,000 (central) and 216,000 (sub-central); Annex XIV services 750,000; works 5,404,000 euros; defence supplies by central government: 140,000 for Annex III products, 216,000 for other products	European Commission, public procurement thresholds, opened 2026-08-21
TED	Tenders Electronic Daily, Supplement to the Official Journal of the EU, free access	TED, opened 2026-08-21
GPA and other agreements	treatment no less favourable for signatories, insofar as covered by the EU’s annexes and general notes	Directive 2014/24/EU, Article 25, EU text on legislation.gov.uk, opened 2026-08-21
Kolin, C-652/22	22 October 2024; decided under Directive 2014/25/EU (utilities); operators from third countries without an agreement cannot rely on the directive; admission assessed case by case by the contracting entity; challenges under national law only	Court of Justice of the EU, Press Release No 183/24, opened 2026-08-21
IPI measure on medical devices	Implementing Regulation (EU) 2025/1197; adopted 19 June 2025, effective 30 June 2025; contracts of more than 5 million euros; exclusion of operators originating in China; 50 percent caps on subcontracting and on Chinese-origin devices; five years, renewable; limited exceptions	King and Spalding, European Commission excludes Chinese medical device manufacturers from EU public procurement contracts (law firm publication), opened 2026-08-21
Medical devices, authorised representative	manufacturer not established in a member state designates a sole authorised representative	Regulation (EU) 2017/745, Article 11, as adopted, on legislation.gov.uk, opened 2026-08-21
Public authorities’ payment term	30 calendar days; member states may extend to 60 days for public entities providing healthcare duly recognised for that purpose	Directive 2011/7/EU, Article 4, EU text on legislation.gov.uk, opened 2026-08-21
Central and sub-central authorities	central government authorities are those listed in Annex I; sub-central are all others	Directive 2014/24/EU, Article 2, EU text on legislation.gov.uk, opened 2026-08-21
Medical devices, importers	importers place only conforming devices on the Union market; indicate name, registered place of business and contact address on the device, packaging or accompanying document	Regulation (EU) 2017/745, Article 13, as adopted, on legislation.gov.uk, opened 2026-08-21