EU Compliance

CE Marking for Imported Manufactured Goods

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/ECProduct 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
Collect technical file from supplier
Technical drawings, risk assessment, test reports to harmonised standards (EN ISO, EN IEC), BOM listing all hazardous substances.
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
Translate declarations and manuals
User manual must be in the official EU language(s) of the country where you place the product. DoC must be in English + national language.
07
Draft and sign Declaration of Conformity
The EU importer signs as 'person responsible for placing on the market'. Include directive list, harmonised standards used, notified body (if applicable).
08
Affix CE mark
CE mark format: proportions per Annex II of Regulation 765/2008. Minimum height 5 mm. Do not add a space between C and E.
09
Keep technical file for 10 years
EU Market Surveillance Authorities can request technical files up to 10 years post-sale. Retain all supplier test reports, DoC, 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 EU importer. When you bring a product from outside the EU, you become the 'responsible person' under EU product safety law — you hold the Declaration of Conformity and are legally liable if the product is non-compliant.

What is an Authorised Representative and do I need one?

An Authorised Representative (AR) is an EU-established entity that holds the technical file and Declaration of Conformity on behalf of a non-EU manufacturer. If you are the EU importer, you ARE the responsible person — you don't need an AR. You only need an AR if a non-EU manufacturer wants to self-affix CE without going through an EU importer.

Can a Chinese manufacturer CE-mark parts before shipment?

The manufacturer can test and prepare the technical file, but they cannot independently affix CE marking for EU market without an EU responsible person (importer or AR). The EU importer signs the Declaration of Conformity and takes legal responsibility.

Which EU directives apply to CNC machined metal parts?

It depends on the end use. Machinery Directive (2006/42/EC) applies if the part is a machine or machine 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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