Article

How can I be certain that I carried out the certifiction correctly?

Compliance Expert Soufyan Lamdini explains

Products that are manufactured and tested according to harmonized standards, are presumed to be in compliance with the essential requirements of the applicable directive that refer to this standard.

In addition, the following principles shall be carried out when CE Marking take place by Self Certification:

– The manufacturer, his authorized representative or the importer (economic operator) must ensure and declare that the products meet the essential requirements of directives applicable to them;

– The economic operator shall, on each product affix the CE-marking and draw up the EC declaration of conformity;

– The economic operator shall establish the technical documentation (Technical File) and keep it for at least ten years after the last product available for inspection by the competent national authorities;

– Based on the Technical File economic operator must be able to demonstrate whether the product complies with the essential requirements of the applicable directive (s). When applicable, the Technical File also covers the design, manufacture and operation of the product;

– The economic operator shall take all necessary measures to ensure that the products are manufactured in accordance with manufacturing process as drawn up in the Technical File and with the essential requirements of the Directive (s) that are applicable on the product.

Was this answer helpful?

Was this answer helpful?

Related questions

What should I take into account when I self certify my product?

The following steps should be carried out when the manufacturer applies the CE marking by means of self-certification: The manufacturer,…

What are the pros and cons of self-certification?

Thinking about CE marking self-certification? Here’s what you should know. Before you can sell your product within the European Union,…

Can I compile the documents my self certify?

Yes, in accordance with the requirements of the applicable Directive, as manufacturer you shall carry out the safety assessment procedures…

Want to know more?

Check out our blog for the latest insights. Can't find what you're looking for? Our experts are happy to help.