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EUProcess guide

# CE Marking with a Contract Manufacturer

CE marking responsibility follows the brand name on the product — not the factory that builds it. If your name is on the product, you are the manufacturer in the eyes of EU law. Understanding who owns CE responsibility at each stage of an OEM or ODM supply chain is the foundation of defensible compliance.

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At a glance

Manufacturer scenarios

4

Key contract provisions

6

Technical file control steps

5

## Who is the manufacturer in different supply chain scenarios

### Own-design, contract-built (OEM)

Responsible party: Brand owner / commissioning company

You designed the product and a CM builds it to your specification under your brand. You are the manufacturer. You hold CE marking responsibility regardless of where the CM is located. The CM builds to spec; you own the Declaration of Conformity and technical file.

### ODM product, resold under your brand

Responsible party: Brand owner (reseller)

You buy a product designed by an ODM manufacturer and sell it under your own brand or name. By placing it under your name, you become the manufacturer for CE purposes. You cannot rely on the ODM's original CE marking — you are now the responsible party and need the complete technical file.

### ODM product, sold under ODM's original brand

Responsible party: Importer

You import and sell an ODM product under the original manufacturer's brand. You are an importer — with specific duties including verifying CE marking is in place, maintaining importer records, and cooperating with authorities — but the ODM remains the manufacturer.

### Substantially modified product

Responsible party: Modifier becomes manufacturer

If you make substantial modifications to an existing CE-marked product before resale, you may become the manufacturer for the modified product. The threshold for 'substantial modification' varies by directive — generally changes that introduce new hazards or affect the original compliance basis.

## Key contract provisions to include with your CM/ODM

01

Right to receive and review the complete technical file for the product, including all test reports

02

Notification obligation for the CM/ODM to inform you of any design changes, component substitutions, or manufacturing process changes that could affect compliance

03

Component and supplier change control — prohibition on PCB layout changes, antenna modifications, or alternative component use without written approval

04

Retention of product samples by the CM for the required technical file retention period (minimum 10 years from last manufacture)

05

Audit rights — ability to inspect the CM's manufacturing quality controls and component sourcing records

06

Indemnity provisions if non-compliant products are shipped despite agreed specifications

## Technical file control best practices

Maintain your own copy of all test reports, not just the CM's copy — test reports are the most important document in the technical file

Version-control your design documents and ensure the CM's build specifications exactly match the tested configuration

Establish a formal process for PCB revision control — even minor changes to track routing near radio components can affect RF performance and compliance

Require material declarations and RoHS compliance records for all components by supplier part number and date code

Document the chain of evidence: component approved → PCB assembled → tested configuration → test reports → Declaration of Conformity

## Frequently asked questions

### Can I use an ODM's existing CE test reports for my product?

Only if: (1) the product being sold is identical to the product that was tested, (2) you have the right to reference those test reports in your own Declaration of Conformity, and (3) the tests were performed to current harmonised standards by an accredited laboratory. If the ODM has changed any hardware since the tests were performed, or if the test standards have been revised, the existing reports may not support your CE Declaration. A written agreement with the ODM granting you the right to use the test reports is essential.

### What happens if my CM changes a component without telling me?

You are still legally responsible as the manufacturer. Market surveillance authorities will hold you accountable for the CE marking on products bearing your name and address, regardless of whether the non-conformity was caused by your CM's unauthorised change. This is why technical file custody — particularly for test reports tied to a specific hardware configuration — and contractual change control obligations are so important when using a CM.

### Does my EU Authorised Representative need to hold the technical file?

No. The EU Authorised Representative must be able to forward regulatory correspondence to the manufacturer and cooperate with market surveillance authorities — they do not need to physically hold the technical file. The technical file must be made available to authorities on request, and the manufacturer (even a non-EU manufacturer) is responsible for its completeness and accuracy.

### If my ODM already has CE marking, do I need to redo everything?

If you are reselling the product under the ODM's original brand name with their CE marking intact, and you are acting as an importer (not a manufacturer), you do not need to redo the CE process — but you must verify the CE marking is legitimate, maintain importer records, and cooperate with authorities. If you rebrand the product under your own name, you become the manufacturer and must take full CE marking responsibility, including access to and responsibility for the technical file.

**Disclaimer:** Educational resource only. CE marking responsibility allocation in supply chains has legal implications. Consult qualified legal and compliance professionals when establishing your CM/ODM relationships.

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