By applying the CE marking and providing the associated EU Declaration of Conformity (DoC), a manufacturer or importer is confirming that a product meets the requirements of all applicable EU Directives. However, common misconceptions about CE marking mean that products often don’t comply. Also, due to language issues, other manufacturers who mean well are misunderstanding the requirements of a complex set of Directives – applying CE marking to products that should fail tests.
If the CE marking is the manufacturer’s declaration that the product meets the requirements of the applicable EC Directives, how can they ensure they are on the right track to compliance?
Who is responsible?
It is the manufacturer or importer of a product that is responsible for the compliance through a process of self-declaration, which manifests itself as the DoC. This is a formal statement that a product complies with applicable Directives and standards. It must be signed by the responsible person within the organisation and that signatory may be subject to prosecution, or even imprisonment, if the equipment is found not to comply.
The DoC must include, amongst other things:
· Name and address of the manufacturer (or their authorised representative)
· Description of the product – including type, model and any other information that clearly relates the equipment to the declaration
· Reference to the standards applied
· Identification of the signatory
Unlike certifications to show compliance with Directives, a test house will not assume responsibility for the product, but can help with the self-declaration process. Some Directives may require you to consult a Notified Body (Medical, Machinery etc.)
Supply chain assurances
The New Legal Framework for EU Directives redefines the responsibilities of economic operators – manufacturer, authorised representative, importer and distributor. There are also rules which relate to traceability of a product and how it should be identified, depending on whether the manufacturer is within or outside the EU.
By law, whoever is placing a product for sale in the EU market, is responsible for its compliance. Companies buying directly from abroad therefore need to be increasingly vigilant and take steps themselves to ensure compliance, rather than rely on others to take on the burden of proof.
To meet the demand for low-cost goods, companies are increasingly buying electronic products and components directly from manufacturers abroad. However, many non-EU exporters are still unaware of or unsure about compliance requirements. Therefore, an EU company’s reliance on the CE marking applied by a non-EU manufacturer could mean that they are purchasing unsafe goods.
Customs officials keep watch for the CE marking on products, and those businesses importing into the EU are required to hold evidence of the test reports and certificates in the form of a technical file that proves compliance. If such information is missing, this may result in their prosecution as they have a legal responsibility for ensuring proof of compliance.
The Radio and Telecommunications Terminal Equipment Directive (R&TTE) is an excellent example of how this approach is failing within the electronics industry. Since its introduction in April 2000, the Directive has been the required method for those placing products on to the market to demonstrate compliance of any radio and telecoms equipment that is sold across Europe. This meant that manufacturers or importers could simply sign a declaration of conformity indicating that the product met the Essential Requirements and apply CE marking themselves, provided of course that there was an adequate technical file supporting the claim.
However, a market surveillance report conducted in 2003 in 19 European Conference of Postal and Telecommunications Administrations (CEPT) countries showed that 76 per cent of equipment that relies on the radio spectrum failed to comply with the R&TTE. Another CEPT market surveillance campaign conducted in 2005 showed that 88 per cent of the terminal equipment checked failed to comply with the Directive’s technical requirements.
As the European Commission became concerned about the low level of compliance with the R&TTE for some categories of radio equipment, it has published the new Radio Equipment Directive (RED) 2014/53/EU, which will be applicable from 13 June 2016.
More than safety
Many make the mistake of presuming that CE marking only relates to safety and EMC requirements. European harmonised standards detail technical tests and design requirements to meet essential requirements. Subsequently, products which are shown to meet the essential requirements of more than 20 EU Directives must display the CE marking.
The CE marking Directives which would most typically be applicable to consumer & technical products are – Restriction of Hazardous Substances (RoHS), Low Voltage Directive (LVD), Electromagnetic compatibility (EMC), Radio Equipment Directive (RED), Ecodesign of Energy-related Products (ErP), Energy labelling of Energy-related Products.
A modular approach ensures that CE marking Directives follow the same assessment processes – described in Council Decision 768/2008/EC. CE marking Directives each use one or more module (A to H), which lay out generic assessment methods:
· Module A – internal production control
· Module B – EC type examination
· Module C – conformity to type
· Module D – production quality assurance
· Module E – product quality assurance
· Module F – product verification
· Module G – unit verification
· Module H – full quality assurance
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 don’t 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 offence.
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
· Test reports
· 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.
About the author:
Jean-Louis Evans is Managing Director at TÜV SÜD Product Service and at its sister company, TÜV SÜD BABT –