Can I self-declare CE marking?

Yes, you can self-declare CE marking for many products, provided yours is low-to-medium risk and fully complies with relevant EU harmonized standards. Products like most electronics, standard machinery, and non-sterile/non-measuring Class I medical devices often fall under self-certification.

However, high-risk items (e.g., medical devices, pressure equipment, and certain toys) legally require an independent conformity assessment by an EU-recognized “Notified Body”.

To self-declare, follow these steps:

1. Identify Directives: Determine which EU directives or regulations apply to your product (e.g., EMC, Low Voltage Directive).
2. Apply Standards: Ensure your product meets the essential health, safety, and environmental requirements by following European harmonized standards.
3. Assess & Test: Conduct necessary conformity testing to verify compliance.
4. Compile the Technical File: Create and maintain a technical file containing test reports, risk assessments, and design specifications. This must be kept for 10 years and shown to market authorities upon request.
5. Draft the Declaration: Sign an official EU Declaration of Conformity stating sole responsibility for compliance.
6. Affix the CE Mark: Place the CE mark on the product, ensuring it is visible, legible, and at least 5mm high.