EU and UK market entry for U.S. manufacturers
10 min read
EU and UK market entry for U.S. manufacturers: what differs from home, when you need an EU Authorized Representative and the order of the steps.
You make products in the U.S., and now a distributor in Germany, a retailer in England and customers in Northern Ireland want them. Your U.S. test reports and English manual will not get you there on their own: the EU, Great Britain and Northern Ireland are three legal markets, and each asks who proves conformity and who answers to the authorities. This guide to EU and UK market entry for U.S. manufacturers shows what differs from home, when U.S. companies need an EU Authorized Representative and in which order to act.
What works differently from selling in the U.S.
Many U.S. teams arrive with test reports, a safety certification from a Nationally Recognized Testing Laboratory (NRTL) and, for electronics, an FCC equipment authorization. The U.S. International Trade Administration (ITA) warns that products tested and certified to U.S. regulations and standards "are likely to have to be retested and re-certified to EU requirements" (ITA, EU Standards for Trade (opens in a new tab), last published 5 May 2026).
| Topic | Common assumption | EU and UK |
|---|---|---|
| Proof of conformity | A lab listing proves compliance | Often your own assessment, technical file and Declaration of Conformity |
| Local contact | The buyer deals with authorities | An economic operator in the EU; in Great Britain, a UK importer or UK authorized representative |
| Consumer products without specific rules | No obligations | The General Product Safety Regulation (GPSR): risk analysis and technical documentation (Article 9(2)) |
The biggest shift is who proves conformity. For many CE-marked products, it is you: under the Low Voltage Directive, the manufacturer "ensures and declares on his sole responsibility" that the equipment meets the requirements (Annex III of Directive 2014/35/EU (opens in a new tab)). A notified body, an assessor designated by an EU member state, takes part only where the act requires it.
Three legal markets: the EU, Great Britain and Northern Ireland
Great Britain (England, Scotland and Wales) applies British law and continues to recognize CE marking for many product types alongside the British UKCA (UK Conformity Assessed) marking (gov.uk guidance (opens in a new tab), updated 21 August 2026); see UKCA or CE marking.
Northern Ireland follows EU product rules under the Windsor Framework, including the GPSR since 13 December 2024. In these rules, references to the EU include Northern Ireland: an importer or Authorized Representative that must be established in the EU may be established in Northern Ireland, and goods shipped in from Great Britain count as imports (Commission Blue Guide 2022 (opens in a new tab), section 2.9.6). The UK Office for Product Safety and Standards (OPSS) accepts one economic operator for both, "regardless of which of the two jurisdictions it is established in" (OPSS guidance (opens in a new tab)). A company established only in Great Britain does not qualify; see GPSR in Northern Ireland.
The UK government consulted on a new product safety framework until 23 June 2026; as of 20 October 2026, no outcome had been published. Our EU and UK market entry checklist compares all three markets.
Do U.S. companies need an EU Authorized Representative?
Before a product is placed on the EU market, an economic operator established in the EU must be responsible for it (Article 4(1) of Regulation (EU) 2019/1020 (opens in a new tab) for most CE-marked products, Article 16(1) of the GPSR, Regulation (EU) 2023/988 (opens in a new tab) for other consumer products). This can be an EU manufacturer, an importer, an Authorized Representative with a written mandate or, only if none of these exists, a fulfillment service provider (Article 4(2) of Regulation (EU) 2019/1020). Your sales route decides:
- An EU distributor buys from you and imports. It is the importer and can be your economic operator.
- You ship directly to EU customers from your own shop or a marketplace account: there is usually no importer, so you need an Authorized Representative.
- You use several channels. One representative can cover all of them, plus Northern Ireland.
- You have an EU subsidiary. It can act as importer or, with a written mandate, as representative; see Authorized Representative or importer.
By law, the representative at least verifies that the EU Declaration of Conformity and technical documentation have been drawn up, keeps them available, answers authority requests, reports risks and cooperates on corrective action (Articles 4(3) and 5(1)). You remain the manufacturer; the representative acts within the agreed scope and mandate.
In Great Britain, your EU representative does not count: the UK importer and, depending on the product, a UK authorized representative take the local roles (gov.uk guidance). A UK Responsible Person is a sector role, for example for cosmetics; see UK Responsible Person.
EU and UK market entry in seven steps
Our GPSR compliance checklist details each duty; here is the order for all three markets.
- Classify each product. Find the EU acts that apply and whether they require CE marking; without one, the GPSR covers consumer products. See does my product need CE marking.
- Map sales routes per market. Note who places the product on the market in the EU, Great Britain and Northern Ireland.
- Appoint the local roles. An Authorized Representative for the EU and Northern Ireland wherever no importer takes the role; for Great Britain, an agreed UK importer or, where required, a UK authorized representative.
- Test, document and declare. Apply EU harmonized standards, build the technical file and sign the EU Declaration of Conformity as manufacturer; keep both for 10 years (for electrical equipment, Article 6(2) and (3) of Directive 2014/35/EU). UKCA needs a UK declaration. See who signs the declaration.
- Design labels and manuals. Your name and address on the product where possible; your EU operator on the product, packaging, parcel or an accompanying document (Article 4(4) of Regulation (EU) 2019/1020); the UK importer on products for Great Britain; instructions in the language each country sets; see which address goes where and language requirements.
- Settle EPR before the first sale. The producer, which can be you or your importer, registers batteries in each EU country where it first makes them available (Article 55(2) of Regulation (EU) 2023/1542 (opens in a new tab)); electrical equipment and packaging have national registers too. In Germany, non-EU producers without an establishment there must appoint an EPR representative for all three (§ 8 ElektroG, § 40(2) BattDG, § 5(2) VerpackDG); see electrical equipment, packaging and batteries.
- Launch, then keep it running. Complete every EU and Northern Ireland listing (Article 19 GPSR), handle complaints and keep the file current; see the duties after launch.
Example: a U.S. maker of air purifiers
A U.S. company makes mains-powered air purifiers without radio functions and sells replacement filters. It plans its own online shop for consumers in Germany and an importing distributor in England, which also supplies stores in Northern Ireland.
The purifiers fall under the low voltage, electromagnetic compatibility and hazardous substances directives, so Article 4 of Regulation (EU) 2019/1020 applies; the filters, without CE legislation, fall under Article 16 GPSR. One EU Authorized Representative takes both under one written mandate and also covers the units sent on to Northern Ireland. In Great Britain, the distributor is the importer, and the purifiers may keep their CE marking (gov.uk sector table (opens in a new tab)).
| Topic | U.S. launch | EU and UK launch |
|---|---|---|
| Label and box | U.S. address | Manufacturer and representative details; UK importer on units for Great Britain |
| Manual | English | German for Germany; English for Great Britain and Northern Ireland |
| Take-back and packaging | Not planned | Electrical waste and packaging: registration and EPR representative in Germany |
Common mistakes U.S. manufacturers make in the EU and the UK
- Treating a U.S. listing as EU approval. Only the CE marking attests conformity with the EU acts that provide for it (Article 30(4) of Regulation (EC) No 765/2008).
- Waiting for someone to issue the CE marking. You or your Authorized Representative affix it after the conformity assessment (Article 30(1)).
- Putting only your U.S. address on the box. The EU and Northern Ireland need the details of an economic operator established in either; one in Great Britain does not qualify.
- Expecting the representative to take over the product. Design and technical documentation stay with you by law (for electrical equipment, Article 7(2) of Directive 2014/35/EU); the representative performs only the tasks in its mandate.
Conclusion: one project, three markets
EU and UK market entry for U.S. manufacturers works best as one project: the EU and Northern Ireland can share one economic operator, while Great Britain has its own roles and rules.
Representa supports market entry planning through Market Entry Strategy in our Consulting pillar and through compliance consulting. As your EU Authorized Representative, we act within the agreed scope and mandate, and we also cover the United Kingdom as part of Representation. Representa is listed in the U.S. ITA directory of CE marking consultants. You remain the manufacturer and responsible for your product.
Frequently asked questions
Do U.S. companies need an EU Authorized Representative?
Not always. For most CE-marked and consumer products, an economic operator established in the EU must be responsible: an EU manufacturer, an importer, an Authorized Representative with a written mandate or, as a fallback, a fulfillment service provider (Article 4(2) of Regulation (EU) 2019/1020, Article 16(1) GPSR). Direct sellers usually have no importer and need a representative.
Is a U.S. safety certification or FCC authorization valid in the EU?
Not on its own. The product must conform to the EU acts that apply to it, documented in a technical file and declared in an EU Declaration of Conformity. The U.S. International Trade Administration notes that products certified to U.S. standards are likely to need retesting to EU requirements. A U.S. mark may stay on the product if it does not mislead about the CE marking or impair it.
Does an EU Authorized Representative also cover the UK?
It covers Northern Ireland, where EU product rules apply and an operator established in the EU or Northern Ireland qualifies (Commission Blue Guide 2022, section 2.9.6; UK Office for Product Safety and Standards). It does not cover Great Britain, where the UK importer and, depending on the product, a UK authorized representative established in the UK take the local roles.
Can I sell CE-marked products in Great Britain?
For many product types, yes. Under the Product Safety and Metrology etc. (Amendment) Regulations 2024, Great Britain recognizes CE marking alongside UKCA, for example for electrical equipment and electromagnetic compatibility. UKCA is needed where a UK Approved Body assesses the product. Instructions must be in English, and the UK importer's name and postal address go on the product.
Which languages do instructions need in the EU and the UK?
In the EU, each member state sets the language for instructions and safety information (Article 9(7) GPSR; Article 6(7) of the Low Voltage Directive for electrical equipment). In Great Britain and Northern Ireland, UK government guidance requires clear instructions in easily understandable English.
