Conformity assessment of products to EU directives and regulations: from the technical file to the EU declaration of conformity and the CE mark.
CE marking declares that a product meets the essential requirements of the EU directives and regulations that apply to it: safety, health, environment. Without it a product cannot be placed on the market of the European Economic Area.
The route depends on the product and its risk class: from a manufacturer self-declaration with a technical file to third-party assessment by a notified body. We define the route, review the file, coordinate testing and issue the documents.
Industrial machines, lines, tooling.
Electrical equipment and electromagnetic compatibility.
Personal protective equipment.
Construction products: DoP and CE.
Pressure equipment.
Medical devices with ISO 13485.
| MODULE | WHAT IT MEANS | WHO ASSESSES |
|---|---|---|
| A | Internal production control: manufacturer declaration with technical file | Manufacturer (we review the file) |
| B + C / D / F | EU type-examination plus production control, quality assurance or product verification | Notified body |
| G | Unit verification: single products and installations | Notified body |
| H | Full quality assurance: design and production under a certified QMS | Notified body |
Describe the product: we identify the directives, the module and the test programme.