CE Certification

How It Works

1. 1

   Directive identification

   We identify which EU Directives apply to the product (e.g., LVD + EMC Directive for electrical equipment, MDR for medical devices).

2. 2

   Gap analysis

   The product is assessed against the essential requirements of each applicable Directive.

3. 3

   Testing

   Where required, the product is tested at an EU-recognised laboratory against the relevant harmonised standards.

4. 4

   Technical file

   The complete technical file is compiled: product description, drawings, test reports, risk assessment, and Declaration of Conformity.

5. 5

   Notified Body (if required)

   For higher-risk product categories, a Notified Body is engaged for the conformity assessment module required by the Directive.

6. 6

   CE Mark applied

   The Declaration of Conformity is signed and the CE Mark is affixed to the product and packaging.