FAQ

• • The CE marking is the Manufacturer’s declaration that the equipment complies with the applicable EU Directives. For most products sold in the European Community the use of the CE marking and the Declaration of Conformity is mandatory. With the exception of certain product categories expressly indicated in the Directives, the manufacturer may self-declare conformity with the essential requirements prescribed in the Directive by affixing the CE marking. The CE marking is an initials that must be visibly and indelibly affixed to each product to certify that it meets the essential requirements laid down by one or more Community Directives. The CE marking means “Conformité Européenne”, literally translated “European Conformity”.The CE marking allows products to enter the European market, but it is not a mark of approval, certification or quality, nor can it be used as a marketing tool.The CE marking only states that the manufacturer or distributor takes responsibility for the product, allowing it to circulate freely in Europe. The CE marking must not be confused with other approval or certification marks issued by certification bodies.

    As stated in the “European Commission Guide to the Implementation of Harmonised EU Directives”:
    “Manufacturers are responsible for ensuring that the products they put into circulation comply with the relevant regulations. Where these regulations do not require mandatory certification, manufacturers often voluntarily apply for certification to ensure that their products meet the requirements imposed by law’.

    The route to attainment
    The process for obtaining the marking depends on the directive; in general, however, it is necessary:

    The identification of all Directives applicable to the product
    Analysis of the essential protection and safety requirements
    Analysis of the risks associated with the use of the product
    Identification of the harmonised standards applicable to the product
    The performance of the tests, measurements or verifications prescribed by the harmonised technical standards
    The preparation and maintenance of the Technical File
    Purposes
    The main purposes of CE marking are

    To indicate the conformity of the product to the applicable directives and therefore to the essential safety requirements
    To allow the product to be placed on the market
    To ensure the free movement of goods
    To allow the withdrawal of non-compliant products by the authorities or customs

European Union and member state flags

The European Union (EU) has implemented a system to protect the health of consumers and workers as well as sales conditions and the environment.

Under the ‘New Approach’, EC Directives were created to ensure compliance with safety and quality standards within the European Union and certain EFTA (European Free Trade Association) members.

In 1994, the EU/EC and EFTA merged to create the European Economic Area (EEA), the largest economic area in the world. Participating members include Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom.

Most of the legislation and procedures are now in place and the scope of harmonisation has been completed. In addition, numerous standards (Norms) for product safety, machinery, electromagnetic compatibility and telecommunications have been published to support the essential requirements of the Directives. The standardisation process is constantly evolving, with procedures established to cover all aspects of conformity.

When a European Standard (EN) exists, it is always recommended to refer to it to ensure compliance with the European Directives. In some cases, non-EN standards may also be considered, but the choice must be justified. The use of non-European alternatives may be unjustified before the court and may result in the product being found to be non-compliant. Only through harmonised European Standards, together with a unified evaluation process accepted by all participating countries, is it possible to dispense with redundant testing and submission of products to each individual member state institution.

Product conformity requires an understanding of the purposes and methods for achieving it. The purposes are explained in laws, known as Directives. The different Directives define the essential requirements. The ways to achieve the aims are explained in technical standards, known as harmonised standards (EN). Directives and standards must be taken into consideration together with the design evaluation criteria for the product. The most important consideration must be the protection of the end consumer (user, operator, buyer, etc.), for whom the manufacturer and/or distributor must reduce the risks in the use of the product as much as possible.

Presumption of Conformity
This is an expression associated with products that comply with harmonised European Standards. National government authorities are obliged to recognise that equipment produced in accordance with Harmonised Standards, published in the Official Journal of the European Community and transposed into national law, is presumed to comply with the essential requirements of the applicable Directives. When a product does not meet the appropriate EN Harmonised Standards, the presumption of conformity does not exist.

The Directives tell us why we must comply with them and what might happen if we ignore the law. But it is the EN Harmonised Standards that show us how to meet them (design and evaluation) by providing us with guidelines.

The Technical File is required by the Directives to document the conformity assessment and design of the product. The Technical File must be compiled by the manufacturer or authorised representative and contains documents relating to the design, manufacturer, test reports and operational information demonstrating conformity as required by the Directives.

Documents making up the technical file (for example)

Declaration of conformity (and/or certificates)
Name and address of the manufacturer and identification of the product
Name and address of the European distributor, if applicable
List of the harmonised standards followed and/or the solutions adopted to meet the essential requirements
Description of the product (model, name, etc.)
User manual
Test reports
Risk analysis
Design details, list of components, circuits and diagrams, with everything you need to understand the solutions adopted to meet the essential requirements.

Depending on the type of product, there are different types of Guidelines to be applied:

Basic Directives
They apply to all manufacturers of products and are primarily aimed at trade. It is important to understand the implication of these Directives, especially with regard to manufacturers. Examples of Basic Directives that affect most manufacturers and suppliers are:

General Product Safety Directive – 2001/95/EEC
Product Liability Directive – 1999/34/EEC

Generic Directives
They apply to a specific range or group of products, such as products that operate with a certain voltage limit (LVD, Low Voltage) or products that may generate RF emissions (EMC, Electromagnetic Compatibility). These Directives cover a large sector of products such as Information Technology Equipment (ITE), Household Appliances, Lighting Equipment, etc…

Specific Directives
They apply to specific products, such as Telecommunication and Medical Devices, as well as other high-risk products, such as machinery falling under Annex IV of Directive 2006/42/EC, or products used in places with a high risk of explosion falling under the ATEX Directive 94/9/EC.

The involvement of a third party may be mandatory, but not in all cases. If the class or type of product is regulated by the Directive, the Third Party must assess the product and issue the certificate before the CE marking can be affixed. It is necessary to refer to the relevant Directive to see if the involvement of the European Notified Body is mandatory for the product in question.

This type of directive takes precedence over all others.