European Union · General Products

EU CE Marking

A practical guide to EU CE Marking for general products sold in the European Union: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Products covered by EU harmonisation legislation; Importers and brand owners placing goods on the EU market

Authority

EU national market surveillance authorities

Legal basis

Regulation (EC) No 765/2008; Decision No 768/2008/EC

Local representative

The EU importer or authorised representative takes responsibility for the declaration

Timeline

Before placing the product on the EU market

Cost

In-house assessment is low cost; notified body work is priced per product

If you do not comply

Withdrawal from sale, fines, and market bans

Who needs this

Products covered by EU harmonisation legislation
Importers and brand owners placing goods on the EU market

Documents you need

EU declaration of conformity
Technical file with risk assessment
Test reports against the applicable harmonised standards
Instructions and safety information in the required languages

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

EU declaration of conformity
Technical file with risk assessment
Test reports against the applicable harmonised standards
Instructions and safety information in the required languages

How to comply

Identify every directive or regulation that applies
Carry out the conformity assessment procedure
Compile the technical file and sign the declaration of conformity
Affix the CE mark and retain documents for ten years

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: EU CE Marking — European Union
Product category: General Products
Authority: EU national market surveillance authorities
Legal basis: Regulation (EC) No 765/2008; Decision No 768/2008/EC

Documents we already have:
  1. EU declaration of conformity
  2. Technical file with risk assessment
  3. Test reports against the applicable harmonised standards
  4. Instructions and safety information in the required languages

Questions:
  1. Does our product fall under EU CE Marking in the European Union?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before placing the product on the EU market.

In-house assessment is low cost; notified body work is priced per product.

Common rejection reasons

Wrong directive applied to the product
No signed declaration of conformity
Technical file incomplete at inspection

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.