CE Certification

No. For low-risk products (Module A — internal production control), the manufacturer self-declares conformity after compiling the technical file. A Notified Body is required for higher-risk categories such as Class IIa/IIb/III medical devices, PPE Category II/III, and certain machinery.

Yes. Non-EU manufacturers must appoint an EU Authorised Representative who is established in an EU member state. The Authorised Representative's name and address appear on the product labelling alongside the CE Mark.

Over 25 EU Directives and Regulations require CE marking, including: Low Voltage Directive (LVD), Electromagnetic Compatibility (EMC) Directive, Machinery Directive, Medical Devices Regulation (MDR), Toy Safety Directive, PPE Regulation, Construction Products Regulation, and others.

The Declaration of Conformity is product-specific, not time-limited. However, it must be re-done when the product design changes significantly, or when the Directives are revised (as with MDR replacing MDD for medical devices).

Harmonised standards are EU standards (EN standards) whose application gives a presumption of conformity with the essential requirements of the applicable Directive. Products tested against harmonised standards are presumed to conform.

Yes. Most consumer electronics covered by LVD + EMC Directive + RoHS can be self-declared using Module A (internal production control) based on testing against harmonised standards. No Notified Body is required.