Can I CE mark products manufactured outside Europe?

Yes, you can CE mark products manufactured outside Europe. However, the CE mark is not a general marketing badge; it is a legal declaration that your product meets all applicable European health, safety, and environmental standards.

If you are manufacturing outside the EU/EEA, here are the key steps and rules you must follow:

• Compliance is Mandatory: If your product falls under an EU directive or regulation requiring a CE mark (e.g., machinery, medical devices, toys, or electrical equipment), it must be certified regardless of where it was manufactured.
• Notified Bodies: For certain high-risk products, you may need to use an EU-recognized conformity assessment body (a Notified Body) to independently verify the product before affixing the mark.
• Maintain a Technical File: You must compile and maintain a Technical File containing test reports, design details, and risk assessments that prove compliance. This file must be kept for 10 years after the product is manufactured and made available to EU market surveillance authorities upon request.
• EU Representative: If you are a manufacturer outside the EU, you usually need an authorized representative based in the EU to hold your Technical File and act as a point of contact for European authorities.
• The Importer’s Role: If your products are imported into Europe by a third party, the importer assumes legal responsibility to ensure that the CE mark has been correctly affixed and that the manufacturer has completed the necessary procedures