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# CE Marking for Non-EU Companies

The CE marking rules apply equally to all companies selling into the EU market — the difference for non-EU manufacturers is in how the supply chain is structured and who has what legal obligations. Understanding your specific path avoids unnecessary complexity and cost.

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At a glance

Supply chain paths

3

Key steps

8

FAQs

4

## Compliance paths by supply chain structure

### Non-EU manufacturer sells directly to EU consumers (e.g., via own website or Amazon EU)

The manufacturer is treated as the importer for CE marking purposes and must appoint an EU Authorised Representative. Their name and address must appear on the product. They must maintain the technical file and DoC and respond to authority requests.

### Non-EU manufacturer sells via an EU distributor or importer

The EU importer takes on importer obligations — checking manufacturer compliance, adding their own name to the product, maintaining DoC copies. The manufacturer must still prepare the technical file and DoC. An AR may still be required depending on the directive.

### Non-EU manufacturer sells B2B to an EU OEM who rebadges the product

If the OEM places the product on the EU market under their own brand name, they become the manufacturer for CE purposes and take on all manufacturer obligations. The original non-EU manufacturer's role depends on the agreement between the parties.

## Step-by-step CE compliance for non-EU manufacturers

01

Identify which CE directives apply to your product — the same rules apply regardless of where you are based

02

Select and apply harmonised standards — these are internationally published standards, available and applicable to non-EU manufacturers

03

Commission testing at an accredited laboratory — labs in the US, Asia, and globally hold ILAC MRA accreditation for CE testing

04

Prepare technical documentation — this can be prepared anywhere, but must be available to EU authorities on request

05

Draw up an EU Declaration of Conformity and sign it — the manufacturer (even non-EU) signs the DoC

06

Appoint an EU Authorised Representative where required by the applicable directives

07

Ensure product labelling includes your own name/address and the AR's EU address

08

Register in EU databases where required (EPREL for energy-labelled products, EUDAMED for medical devices, etc.)

## Frequently asked questions

### Can a US company sign an EU Declaration of Conformity?

Yes. The EU DoC is signed by the manufacturer, regardless of where they are based. A US, Chinese, or any other non-EU company can sign and take legal responsibility for the DoC. The key requirement is that an EU Authorised Representative is also named — so EU authorities have a contact point within the EU.

### Can I use a US or Chinese test lab for CE marking?

Yes, provided the lab holds ISO/IEC 17025 accreditation from a body that is signatory to the ILAC MRA. Major global testing organisations (SGS, TÜV, Bureau Veritas, Intertek, UL) have accredited labs in the US, China, and across Asia that issue test reports accepted for CE conformity purposes.

### Does Brexit affect UK companies selling into the EU?

Yes. Since Brexit, UK companies are treated as non-EU manufacturers for EU CE marking purposes. They must appoint an EU Authorised Representative and meet the same obligations as any other non-EU manufacturer. UKCA marking is separately required for the UK market. Northern Ireland has a distinct position under the Windsor Framework.

### Do I need a separate entity in the EU to sell CE-marked products?

No — you do not need to incorporate a EU company. You need an EU Authorised Representative (an EU-based individual or company appointed by mandate) whose address appears on the product. This can be a third-party compliance service provider. You do not need to own or control the AR entity.

**Disclaimer:** Educational resource only. Not legal advice. CE marking obligations depend on the specific directives applicable to your product and your supply chain structure. Verify with a qualified compliance professional.

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