Products that fall under a CE marking Directive cannot be imported into the EU unless they show the CE marking, which is simply a manufacturer's self-declaration that the product complies with the relevant European legislation.
See Part 1.
This article originally appeared in EE Times Europe.
On an increasingly technologically level playing field, it is brand reputation that sets one manufacturer apart from another. A significant part of reputation comes from a positive user experience, created through safe and reliable products that satisfy the intended use, meet consumer expectation and donít harm anyone.
For those manufacturers wary of the pitfalls of CE marking self-declaration, and looking to ensure that their products are deemed safe, the IECEE CB Scheme offers something beyond wider access to international markets. In fact, the CB scheme is gaining in popularity because it is more regulated and is controlled by a respected organisation, the IECEE (IEC System for Conformity testing and Certification of Electrotechnical Equipment and Components).
The CB Scheme is the world's first international system for the mutual acceptance of test reports and certificates for electrical and electronic components, equipment and products. It offers a single test that gives manufacturers access to international markets for their electronic products, covering both electrical safety and EMC. It encompasses 22 product categories that include electronics/entertainment, household equipment, toys, portable tools and electrical medical equipment, with the majority of certificates issued covering IT/office equipment, domestic white goods and domestic audio/video products.
Any declaration of conformity needs to be backed up by a technical file, which is the evidence that a product has been tested correctly, demonstrates compliance, and justifies the CE marking on a product.
If a product is deemed to be non-compliant, Due Diligence Defence is the reason you need to have excellent technical documentation as it allows you to prove that that you took all reasonable steps to avoid committing the offense.
Due Diligence is knowing what is required, demonstrating compliance with relevant applicable Directives and declaring that you have met the relevant requirements. You must also be fully prepared to produce a comprehensive technical file. Your technical file is your documented evidence to show that the product properly complies with the requirements of the Directives which apply to it.
What is a technical file?
Your technical file is your documented evidence to show that the product properly complies with the requirements of the Directives which apply to it, and authorities are entitled to demand that it is is provided in any official EU language.
The technical documentation you provide must be such as to enable enforcement authorities to assess the conformity of the product to the requirements of the Directives. It must therefore cover the design, manufacture and operation of equipment, and it can be the same document as your design file for the equipment.
A technical file must include:
- A general description of the equipment
- Conceptual design
- Descriptions and explanations necessary for the understanding of the drawings, and the operation of the equipment.
- A list of the standards applied in full (or in part), and descriptions of the solutions adopted to satisfy the requirements of the regulations /Directive where standards have not been applied.
- A list of components, materials and parts used in the product, including approval information on critical components and materials.
- Results of design calculations made, and examinations carried out
- Product instructions/manuals
- A copy of the DoC.
The CE marking is a visible sign that a product complies with all the relevant standards and Directives. It is therefore essential that manufacturers understand how to apply the vast range of possible relevant standards and Directives in order to ensure both compliance and the saleability of equipment destined for the European market.