Selling in the EU from China: responsible person, CE marking and the distributor route

A manufacturer in mainland China that wants European distributors usually starts with the product and the price. European buyers ask three other questions first: does the product carry the right conformity marking, who in the EU is responsible for it, and are the documents in the local language? This article explains the rules behind those questions, and one measure that applies only to Chinese suppliers in one market: public tenders for medical devices.

Putting it simply: many industrial, electrical and consumer products need CE marking, and products under the main CE acts, as well as consumer products, need an economic operator established in the EU who answers to the authorities for the product. Medical devices need an authorised representative in the EU. Since 30 June 2025, EU public tenders for medical devices (CPV 33100000–33199000) with an estimated value of €5 million or more exclude tenders from companies originating in China and limit Chinese-origin devices to 50% of the contract value, with narrow exceptions. That measure does not apply to private sales or to smaller tenders. Many manufacturers outside the EU sell through an EU distributor that imports, stocks, documents and services the product.

This is not legal advice; check the rules for your product with a compliance adviser.

1. CE marking: the manufacturer takes responsibility

EU product law for many non-food goods, from toys to machinery, is built on the New Legislative Framework, adopted in 2008. The Commission describes it as three acts: Regulation (EC) 765/2008, Decision 768/2008/EC and Regulation (EU) 2019/1020.

Under Article 30 of Regulation 765/2008, the CE marking may be affixed only by the manufacturer or its authorised representative, and only to products for which EU legislation provides for it. By affixing it, "the manufacturer indicates that he takes responsibility for the conformity of the product" with all the applicable requirements. Each product type has its own act with its own requirements.

The importer has duties too. Under the model provisions in Annex I, Article R4 of Decision 768/2008, it must check that the conformity assessment was carried out, the technical documentation exists and the product bears the marking. It must add its own name and address and supply instructions and safety information "in a language which can be easily understood" in the country of sale. So a European importer will ask for your technical file before it orders.

2. An economic operator in the EU, also for online sales

Article 4 of the Market Surveillance Regulation, (EU) 2019/1020, applies since 16 July 2021. A product covered by that Article "may be placed on the market only if there is an economic operator established in the Union" who is responsible for it. That operator can be:

• a manufacturer established in the EU;
• an importer, where the manufacturer is not established in the EU;
• an authorised representative with a written mandate from the manufacturer;
• a fulfilment service provider in the EU, where none of the others exists.

The operator keeps the declaration of conformity and technical documentation available to the authorities, informs them of risks and cooperates on corrective action. Its name and postal address must appear on the product, its packaging, the parcel or an accompanying document (Article 4(3) and (4)).

Article 4(5) lists the acts covered, including those on construction products, personal protective equipment, machinery, low-voltage equipment, electromagnetic compatibility, radio equipment, toys, RoHS and ecodesign. Online sales are included: under Article 6, a product offered online is treated as made available on the EU market if the offer is targeted at end users in the EU.

3. Consumer products: the GPSR responsible person

The General Product Safety Regulation, (EU) 2023/988, applies from 13 December 2024. Article 16 extends the same requirement to consumer products: a product "shall not be placed on the market unless there is an economic operator established in the Union" responsible for the tasks in Article 4(3) of Regulation 2019/1020. The responsible person also checks regularly that the product matches its documentation and labelling rules, and its postal and electronic address must appear with the product.

For online sales, Article 19 requires each offer to show the manufacturer's name and contact details, the EU responsible person where the manufacturer is outside the EU, a picture and identification of the product, and any warnings in the local language. Article 22 places duties on online marketplaces. They must design their interface so that traders can enter this information for each listing, and they must act on authority orders to remove dangerous product offers within two working days. Our guide to the GPSR responsible person covers the options in more detail.

4. Medical devices: an authorised representative

Medical devices follow their own regime. Article 11(1) of the Medical Device Regulation, (EU) 2017/745, says that where the manufacturer is not established in a Member State, a device "may only be placed on the Union market if the manufacturer designates a sole authorised representative". The mandate must be accepted in writing; the representative verifies and keeps the documentation and handles registration. Where the manufacturer has not met its obligations, the representative is liable for defective devices jointly with the manufacturer (Article 11(5)).

Under Article 10(11), the label and instructions must be in the official EU language or languages chosen by the Member State where the device reaches the user or patient.

5. Chemicals in your product: REACH

REACH, Regulation (EC) 1907/2006, requires registration of a substance manufactured or imported in quantities of 1 tonne or more per year (Article 6). Substances intended to be released from articles can also need registration above 1 tonne (Article 7). Normally the EU importer registers. Article 8 allows a manufacturer outside the EU to appoint an "only representative" in the EU to fulfil the importer's obligations instead. This matters mainly for suppliers of chemicals, mixtures or articles that release substances; ask your importer.

6. Public tenders for medical devices: the IPI measure

This is the one rule in this article specific to China.

Commission Implementing Regulation (EU) 2025/1197 of 19 June 2025 was published in the Official Journal on 20 June 2025 and entered into force on the tenth day after publication, 30 June 2025. It is the first measure under the International Procurement Instrument, Regulation (EU) 2022/1031.

What it restricts. Article 1 excludes tenders "submitted by all economic operators originating in the People's Republic of China" in all EU public procurement procedures for medical devices under CPV codes 33100000 to 33199000 with an estimated value of €5,000,000 or more, net of VAT. That is the CPV group "Medical equipments".

Limits on Chinese-origin content. Article 2 applies Article 8 of the IPI Regulation to these procedures. A successful tenderer of any origin must make sure that, for the duration of the contract, goods originating in China represent no more than 50% of the total contract value. It also may not subcontract more than 50% of the contract value to Chinese-origin operators. If it does not comply, it must pay a charge of 10% to 30% of the contract value. Origin of a company follows Article 3 of the IPI Regulation: where it is incorporated and has substantive business operations, otherwise who controls it. A group of tenderers with a Chinese-origin member is also excluded, unless that member accounts for less than 15% of the tender value and is not needed to meet most of a selection criterion. Origin of the devices follows the customs rules in Article 60 of the Union Customs Code. Ask an adviser whether your offer is affected.

Exceptions. A buyer may decide not to apply the measure where only Chinese-origin tenders meet the requirements, or for overriding reasons of public interest such as public health (Article 9 of the IPI Regulation).

Duration. Under Article 6(11) of the IPI Regulation, a measure expires five years after its entry into force, so in June 2030, unless it is extended for five years, adjusted or replaced after a review. It can also be withdrawn or suspended. From 4 September to 27 November 2026 the Commission is consulting on the first review of the IPI Regulation itself and has said it will take this measure into consideration.

What it does not cover. Purchases by private buyers that are not contracting authorities, such as distributors buying stock, are not affected. Tenders below €5 million are not affected; the regulation's own recitals estimate that about 96% of EU procedures for medical devices registered in TED in 2017–2022 were below that threshold, although they made up only about 41% of the total value. Pharmaceuticals (CPV 336), personal care products (CPV 337), laboratory equipment and all other product sectors are not covered. Contracts based on a framework agreement are excluded from the measure under Article 6(5) of the IPI Regulation, although the 50% obligations still apply to such contracts above the EU procurement thresholds where the framework agreement itself was subject to the measure (Article 8(1)). It does not change CE marking, MDR certification or duties.

7. Foreign subsidies in very large tenders

The Foreign Subsidies Regulation, (EU) 2022/2560, is not specific to China: it applies to any tenderer, EU-based or not, that receives financial contributions from non-EU countries. In a public procurement procedure with an estimated value of €250 million or more, a tenderer must notify foreign financial contributions if it, together with its holding companies, subsidiaries without commercial autonomy and main subcontractors and suppliers in the tender, received €4 million or more from one non-EU country in the previous three years. Where the procurement is divided into lots, the lots tendered for must also reach €125 million (Article 28). In a procedure of €250 million or more where the contributions stay below €4 million per country, the tenderer instead lists them in a declaration (Article 29).

8. Check for anti-dumping duties before you quote a price

Some products from some countries carry anti-dumping or countervailing duties on import into the EU. The importer pays them, rates can differ by company, and measures normally lapse after five years unless an expiry review is started.

To check, find the correct product code first. Then open My Trade Assistant on Access2Markets, enter China as the "country from", the EU country as the "country to" and the code, and read the applicable duties. The EU tariff database TARIC lists anti-dumping, countervailing and safeguard duties as measures attached to each code. If the classification is uncertain, the importer can request Binding Tariff Information from customs, which gives legal certainty about the code.

9. The practical route: a European distributor

These rules explain why many manufacturers outside the EU sell through an EU distributor. The distributor that imports your goods becomes the importer, and an importer qualifies as the EU economic operator under Regulation 2019/1020 and the GPSR; set out in the contract who does what. For medical devices you still need an authorised representative under the MDR. The distributor holds stock in the EU, so delivery times can match local competitors. It provides documents in the local language, and handles returns, spare parts and after-sales service.

Public tenders show the same pattern. In Cresques analysis of TED contract award notices for supplies published from 2 November 2023 to 30 October 2026, 95.2% of awards by buyers in Germany went to companies registered in Germany, and 98.7% of awards by buyers in Poland went to companies registered in Poland. Here an "award" is one winner on one lot, and the winner's country is the country of registration as published in the notice (methodology). These are two examples. Many winners sell products made elsewhere, but buyers contract with a locally registered supplier. That supplier is the partner to find.

Before the first conversation, check the lawful way to contact a distributor: in Germany and Poland, for example, a first marketing e-mail needs the recipient's prior consent, companies included (country-by-country rules). Then prepare the documents it will ask for, listed in what a distributor expects from a new supplier.

Checklist

1. Identify every EU act that applies to your product (CE legislation, GPSR, MDR, REACH) and complete the conformity assessment, technical documentation and declaration of conformity.
2. Decide who will be your EU economic operator: the importing distributor, an authorised representative under a written mandate, or your own EU company. For medical devices, appoint a sole authorised representative under MDR Article 11.
3. Put the operator's name, postal address and electronic address on the product, packaging or accompanying document; for online offers, show the details required by GPSR Article 19.
4. Translate labels, instructions and safety information into the official language of each target country.
5. Check your product code for anti-dumping or other duties in Access2Markets and TARIC; request Binding Tariff Information if the code is uncertain.
6. If you supply medical devices for public tenders, check whether a tender is at or above €5 million and in CPV 33100000–33199000, and what the IPI measure means for your offer and your distributor's.
7. For tenders of €250 million or more, check the foreign subsidies notification.
8. Shortlist distributors that already supply your category in the target country, and check the lawful first-contact channel there.
9. Agree stock, after-sales service, spare parts and the economic operator role in the distribution contract.

Where Cresques fits

Cresques shows which companies have won public supply contracts for your product category in a chosen EU country, with the award notices behind each name. When you open a company profile, Cresques researches whether it is an independent distributor, a manufacturer or a manufacturer's own subsidiary, quoting its own website and registers. It states whether a first business e-mail is lawful in that country and drafts a first message in the local language. The free plan includes one market map.