Can the declaration of conformity by someone outside of the EU? (CE marking)  

The responsible organisation based in the EEA is the first point in the supply chain who can: - apply CE marking - produce the Declaration of Conformity (DoC) - compile and hold Technical Documentation

Where the manufacturer is not established within the EEA they can apply CE marking, produce the DoC and compile Technical Documentation.

If they have an authorised representative within the EEA that representative should hold the DoC and Technical Documentation.

For manufacturers outside the EEA with no authorised representative the DoC and Technical Documentation should be held by the first supplier of the equipment within the EEA.

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