Contract manufacturing and OEM production

• Regulation (EU) 2023/988 — GPSR
• Regulation (EU) 2019/1020 — Article 4
• Directive (EU) 2024/2853 — product liability
• Sectoral legislation per product

Who has to appoint one

Companies commissioning production from third-country factories for the EU market. The factory is not the manufacturer in EU law if the product carries your name: you are, with the technical file, the declaration and the ten-year retention.

Thresholds and exemptions

None. Ordering a hundred units under your brand carries the same obligations as ordering a hundred thousand.

What must appear on the label

Your details as manufacturer and the EU responsible person or representative, plus whatever the sectoral legislation requires. The factory's own markings do not discharge your obligations and covering them makes the position clearer, not safer.

Marketplace fields

Marketplaces reject supplier declarations naming the factory when the listing shows your brand, which is the most common reinstatement failure for private-label sellers.

Documentation you must hold

Your own declaration of conformity, your technical file assembled from the factory's material but owned by you, supply agreements giving access to test reports and the right to audit, specification control documents, and traceability records per production batch.

Standards and testing

Per the product category, but with independent verification rather than reliance on factory statements. The recurring failure is that the factory tested a specification it then changed without notice.

Language requirements

All labelling and instructions in the languages of your markets, produced by you.

When it applies

Before the first unit is placed on the market under your brand, and again whenever the specification or the factory changes.

How long records are kept

Ten years, or longer for sectors that require it.

What happens if you do not comply

Full manufacturer exposure: withdrawal, recall at your cost, Safety Gate alerts naming your brand, and civil liability under the recast Product Liability Directive, which names the person who puts their name on a product as liable.

Who enforces it

Market surveillance authorities, customs and the civil courts.

Where the boundary lies

The commercial logic of contract manufacturing and the legal position are opposite: you buy a finished product and you acquire a manufacturer's obligations. Specification drift between the tested sample and the shipped goods is the single most common cause of recalls in this model.

Questions we are asked

The factory says it handles CE — is that enough?

No. If the product is placed on the market under your name you are the manufacturer, and the declaration must be yours, based on a file you hold.

Can we audit instead of testing?

Audits help but do not replace test evidence for the product as shipped. Golden samples and periodic retesting are the practical control.