STAGES OF CE

STAGES OF CE CERTIFICATION

These will often ask questions about the product to classify the level of risk and then refer to the "Conformity Assessment Procedures" chart. This shows all the acceptable options available to a manufacturer to certify the product and affix the CE marking.

Products considered to have a greater risk have to be independently certified by a notified body. This is an organization that has been nominated by a Member State and has been notified by the European Commission. These notified bodies act as test labs and carry out the steps as listed in the directives mentioned above and then decided whether the product has passed. A manufacturer can choose its own notified body in any Member State of the European Union but should be independent of the manufacturer and a private sector organization or a government agency.

In reality the self-certification process consists of the following stages :

Stage 1 : Identify the applicable Directive(s)

The first step is to identify whether the product needs to bear CE marking or not. Not all products are required to bear CE marking, only the products that fall within the scope of at least one of the sectoral directives requiring CE marking. There are more than 20 sectoral product directives requiring CE marking covering, but not limited to, products such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products.

Identifying which directive(s) may be applicable, as there may be more than one, involves a simple exercise of reading the scope of each directive to establish which apply to the product (An example of the scope of the Low Voltage Directive below). If the product does not fall within the scope of any of the sectoral directives, then the product does not need to bear CE marking (and, indeed, must not bear CE marking).

Low Voltage Directive (2006/95/EC)

Article 1 states the Directive covers "any equipment designed for use with a voltage rating of between 50 and 1000 V for A.C. and between 75 and 1500 V for D.C, other than the equipment and phenomena listed in Annex II."

Stage 2 : Identify the applicable requirements of the Directive(s)

Each Directive has slightly different methods of demonstrating conformity depending on the classification of the product and its intended use. Every Directive has a number of ‘essential requirements’ that the product has to meet before being placed on the market.

The best way to demonstrate that these essential requirements have been met is by meeting the requirements of an applicable ‘harmonised standard,’ which offer a presumption of conformity to the essential requirements, although the use of standards usually remains voluntary. Harmonised standards can be identified by searching the ‘Official Journal’ on the European Commission’s website, or by visiting the New Approach website established by the European Commission and EFTA with the European Standardisation Organisations.

Stage 3 : Identify an appropriate route to conformity

Although the process is always a self-declaration process,there are various ‘attestation routes’ to conformity depending on the Directive and classification of the product. Some products (such as invasive medical devices, or fire alarm and extinguisher systems) may, to some extent, have a mandatory requirement for the involvement of an authorised third party or "notified body".

There are various attestation routes which include :

  • An assessment of the product by the manufacturer.
  • An assessment of the product by the manufacturer, with additional requirement for mandatory factory production control audits to be carried out by a third party.
  • An assessment by a third party (e.g. EC type test), with the requirement for mandatory factory production control audits to be carried out by a third party.

Stage 4 : Assessment of the product's conformity

When all of the requirements have been established, the conformity of the product to the essential requirements of the Directive(s) needs to be assessed. This usually involves assessment and/or testing, and may include an evaluation of the conformity of the product to the harmonised standard(s) identified in step 2.

Stage 5 : Compile the technical documentation

Technical documentation, usually referred to as the technical file, relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development and manufacture of the product.

Technical documentation will usually include :

  • Technical description
  • Drawings, circuit diagrams and photos
  • Bill of materials
  • Specification and, where applicable, EU declaration of conformity for the critical components and materials used
  • Details of any design calculations
  • Test reports and/or assessments
  • Instructions
  • EU declaration of conformity
  • Technical documentation can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in the European Economic Area (EEA).

Stage 6 : Make a declaration and affix the CE marking

When the manufacturer, importer or authorised representative is satisfied that their product conforms to the applicable Directives, an EU declaration of conformity must be completed or, for partly completed machinery under the Machinery Directive, an ECU declaration of incorporation.

The requirements for the declaration vary slightly, but will at least include :

  • Name and address of the manufacturer
  • Details of the product (model, description and the serial number where applicable)
  • List of applicable sectoral Directives and standards that have been applied
  • A statement declaring that the product complies with all of the relevant requirements
  • Signature, name and position of the responsible person
  • The date that the declaration was signed
  • Details of the authorised representative within the EEA (where applicable)
  • Additional Directive/standard specific requirements
  • In all cases, except for the PPE Directive, all of the Directives can be declared on one declaration.
  • Once an EU declaration of conformity has been completed, the final step is to affix the CE marking to the product. When this has been done, the CE marking requirements have been met for the product to be placed legally on the EEA market.

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