CE Mark Post Certification
Upon determining compliance with the CE Mark requirements, the manufacturer must affix the CE Mark to its product. The manufacturer must also include a “declaration of conformity” with each shipment. The declaration of conformity essentially allows the manufacturer to acknowledge that the CE Mark directive(s) have been met. The manufacturer must also provide the signature of a company official indicating the company’s responsibility for its CE Mark compliance
The manufacturer must retain a technical file containing the documentation that explains conformity to the CE Mark directive(s) required for its product. Information to be included in the technical file will vary based on the product category, but generally should include the following:
- A detailed documentation on the construction, including drawings
- Test results
The CE Mark technical file must be available at all times and must be presented to any member state authorities that might request the document.
Once CE Mark certification is complete, the manufacturer or an authorized representative in the European Community, must affix the CE Mark to the product, legibly and in a visible location. The CE Marking itself must be at least 5 mm. If the CE Marking is enlarged, the proportions must remain. If the CE Marking cannot be placed on the product, the CE Marking must be placed on the product packaging and / or accompanying documents.
When the product is subject to other Directives covering other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that such products are also presumed to conform to the provisions of those other Directives. If a Notified Body is involved in the production control phase, its identification number must also be displayed.
CE Mark compliance is the perpetual responsibility of the manufacturer, therefore the manufacturer must continually review standards and ensure compliance even as standards change. It is recommended that manufacturers regularly review the EU website since it lists CE Mark standards and directives.
Keystone Compliance assists manufacturers with CE Mark compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your CE Mark needs.
For more information on the CE Mark, please click one of the following links: