CE Marking - Self-certification

Self-certification

Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE marking requirements. If a product has minimal risk, it can be self-certified where manufacturers a Declaration of Conformity and affixes the CE marking to their own product. Manufacturer then must do several things:

1. Decide whether the product needs to have a CE marking and if the product applies to more than one directive it needs to comply with all of them.
2. Choose the conformity assessment procedure from the modules called out by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below:
  • Module A – Internal production control.
  • Module A – Intervention of a Notified Body.
  • 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.

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 Government 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 your product can be CE marked or not. Not all products are required to be CE Marked, only the products that fall within the scope of at least one of the CE Marking Directives. There are more than 20 CE Marking Directives covering, but not limited to, products such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products.

Identifying which CE Directive(s) may be applicable, as there may be more than one, involves a simple exercise of reading the scope of each CE Directive to establish which ones apply to your product (An example of the scope of the Low Voltage Directive below). If your product does not fall within the scope of any of CE Directives, then your product does not need to be CE marked, but is likely to fall within the scope of other product Directive(s).

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 CE Marking Directive has a number of ‘essential requirements’ which the product has to meet.

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.

Stage 3: Identify an appropriate route to conformity

The CE Marking process is always a self-declaration process however 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 some involvement of an authorised third party.

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, you need to ensure that the product meets the essential requirements of the Directive(s). This usually involves some assessment and/or testing, and will often involve ensuring that the requirements of the applicable harmonised standard(s), which were identified in step 2, have been met.

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, Declarations of Conformity for the critical components and materials used
  • Details of any design calculations
  • Test reports and/or assessments
  • Instructions
  • EC 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 Mark

When the manufacturer, importer or authorised representative is satisfied that their product conforms to the applicable CE Directives, they must complete an EC Declaration of Conformity or, for partly completed machinery under the Machinery Directive, an EC 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 CE Marking 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 CE Directives can be declared on one Declaration.
  • Once a Declaration of Conformity has been completed, the final step is to affix the CE mark to the product. When this has been done, the CE Marking requirements have been met for the product to legally placed on the EU market.

Read more about this topic:  CE Marking