EU Compliance

CE Marking for Imported Manufactured Goods

By Norbert Laszanowski · Updated · First published

Importing a product from Asia and selling it in the EU makes you — not the factory — legally responsible for CE compliance. Here's the full importer's guide: which directive applies, what documents you need, and how to write supplier contracts that protect you.

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TL;DR

1. Does your part need CE marking?

CE marking is only required for products covered by specific EU harmonisation legislation. Many B2B manufactured components do not require CE marking — only the finished assembly does.

Directive/RegulationApplies when…Typical parts
Machinery Directive 2006/42/EC (Regulation (EU) 2023/1230 from 20 Jan 2027)Product is a machine, safety component, or interchangeable equipmentMotors, gearboxes, safety guards, presses
Low Voltage Directive 2014/35/EUElectrical equipment 50–1000 V AC or 75–1500 V DCPower supplies, motors, transformers
Pressure Equipment 2014/68/EUPressure vessels, steam generators, fittings > category 1Hydraulic cylinders, valve bodies, pressure tanks
RoHS 2011/65/EU (recast)Electrical/electronic equipment placed on EU marketPCBs, sensors, controllers
General Product Safety (GPSR) 2023/988Consumer products (direct-to-consumer or household use)Consumer electronics, tools, toys
Pure B2B component (no directive)Sold as input to an OEM, not placed on consumer marketPrecision CNC brackets, custom extrusions

2. The 9-step CE compliance checklist for importers

01
Identify applicable directives
Check Annex I of each relevant directive against your product specifications.
02
Determine conformity assessment route
Most machinery: self-assessment using harmonised standards. Annex IV machinery (presses, explosion-proof): Notified Body certification required.
03
Get the technical file from the manufacturer
Technical drawings, risk assessment, test reports to harmonised standards (EN ISO, EN IEC), BOM listing hazardous substances. It stays with the manufacturer, but you must be able to make it available to authorities on request.
04
Verify harmonised standards used
Standards cited must be in the EU Official Journal at the publication date of your DoC. Check OJEU list before signing off.
05
Commission conformity tests if needed
For Annex IV, EMC, or LVD: may require testing at an accredited laboratory. Supplier's internal tests are insufficient for some directives.
06
Check instructions and labelling
Instructions and safety information must be in a language easily understood by users in each country where you sell; the Declaration of Conformity must be translated into the language(s) that country requires.
07
Verify the Declaration of Conformity
The manufacturer draws up and signs it, listing the legislation, harmonised standards and notified body (if any). If you sell under your own name or brand, you are the manufacturer and sign it yourself.
08
Check the CE mark and your details on the product
The manufacturer affixes CE in the format of Annex II of Regulation (EC) 765/2008 (minimum 5 mm high). As importer, add your name, registered trade name and postal address to the product or its packaging.
09
Keep records for 10 years
Keep a copy of the Declaration of Conformity for 10 years after the product is placed on the market and make sure the technical file can be produced on request. Retain supplier test reports and correspondence.

3. Supplier contract clauses you must include

Your purchase order or supply agreement with the Asian manufacturer should include these clauses to protect your CE liability position:

  • Conformity obligation — "Supplier warrants that goods comply with [list of directives] and will provide the technical file on request within 5 business days."
  • Notification of change — "Supplier will notify Buyer within 14 days of any change to materials, components, production process, or subcontractors that may affect compliance."
  • Audit rights — "Buyer or its representative may audit production processes, test records, and supplier chain documentation with 10 business days' notice."
  • Indemnity — "Supplier indemnifies Buyer for all costs arising from product recall, market withdrawal, or regulatory action attributable to non-conforming goods."
  • Traceability — "Each delivery shall be marked with batch/lot number and manufacturing date. Supplier retains traceability records for 10 years."

Frequently asked questions

Who is responsible for CE marking on imported goods?

The manufacturer carries out the conformity assessment, draws up and signs the EU Declaration of Conformity and affixes the CE mark. As the EU importer you must check that this was done, put your name and address on the product, keep a copy of the Declaration for 10 years and cooperate with market surveillance authorities. If you sell the product under your own name or brand, you take on all of the manufacturer's obligations.

What is an Authorised Representative and do I need one?

An Authorised Representative (AR) is an EU-established entity a non-EU manufacturer appoints in writing to carry out some of its obligations, such as keeping the Declaration of Conformity and technical file available to authorities. For products covered by Article 4 of Regulation (EU) 2019/1020 there must be an EU-based economic operator — often the importer itself — so an AR is optional when you import and fulfil that role.

Can a Chinese manufacturer CE-mark parts before shipment?

Yes — affixing the CE mark is the manufacturer's job, after it has completed the conformity assessment and signed the Declaration of Conformity. What it cannot do is place the product on the EU market alone: for most CE-marked products an EU-based economic operator (the importer, an authorised representative or a fulfilment service provider) must be identified on the product.

Which EU directives apply to CNC machined metal parts?

It depends on the end use. The Machinery Directive (2006/42/EC) — replaced by the Machinery Regulation (EU) 2023/1230 from 20 January 2027 — applies if the part is a machine, partly completed machinery or a safety component. Pressure Equipment Directive (2014/68/EU) applies to pressure-bearing parts. General product safety rules apply to consumer goods. Many B2B CNC parts sold as components (not finished machines) don't require CE marking at all — check with your legal counsel.

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Sources

  1. Decision No 768/2008/EC — common framework for marketing products (importer obligations, Annex I Article R4)
  2. Regulation (EU) 2019/1020 on market surveillance (Article 4: EU-based economic operator)
  3. Regulation (EU) 2023/1230 on machinery (applies from 20 January 2027)
  4. Directive 2006/42/EC on machinery (applies until 19 January 2027)
  5. Regulation (EU) 2023/988 on general product safety (GPSR)
  6. The ‘Blue Guide’ on the implementation of EU product rules 2022