How to place a CE marking on a product

时间：2024-01-16

Before you place a CE marking on a product, you need to establish which EU New Approach Directives apply to your product. You must not attach a CE marking to a product outside the scope of the directives.

The process you follow depends on the directives that apply to your product.

1. Identify the directive(s) and harmonised standards applicable to the product

There are more than 20 directives setting out the product categories requiring CE marking. The essential requirements that products have to fulfil, for example safety, are created at EU level and are set out in general terms in these directives. Harmonised European standards are issued with reference to the applied directives and express the essential safety requirements in detailed technical terms.

2. Check the product-specific requirements

It is up to you to ensure that your product complies with the essential requirements of the relevant EU legislation. The use of harmonised standards remains voluntary. You may decide to choose other ways to fulfil these essential requirements. If you don’t follow the safety requirements of a standard as it is written you will need to show that your product is as safe, by presenting the relevant documentation.

3. Identify whether an independent conformity assessment is required from a Notified Body

Each directive covering your product specifies whether an authorised third party (Notified Body) must be involved in the conformity assessment procedure necessary for CE marking. This is not obligatory for all products, so it is important to check whether the involvement of a Notified Body is required. These bodies are authorised by national authorities and officially ‘notified’ to the European Commission and listed on the NANDO (New Approach Notified and Designated Organisations) database.

UK conformity assessment bodies can no longer carry out mandatory conformity assessment for products being placed on the EU market.

4. Test the product and check its conformity

If you manufacture a product it is your responsibility to test the product and check its conformity to the EU legislation (conformity assessment procedure). One part of the procedure is, as a general rule, a risk assessment. By applying the relevant harmonised European standards, you will be able to fulfil the essential legislative requirements of the directives.

5. Draw up and keep available the required technical documentation

If you manufacture a product you need to establish the technical documentation required by the directive(s) for the assessment of the product’s conformity to the relevant requirements, and for the risk assessment. You must be able to present the technical documentation and EC DoC to the relevant national authorities, if requested.

6. Placing the CE marking on your product and EC Declaration of Conformity

The CE marking must be placed on the product by the manufacturer, or by his authorised representative within the EEA or Turkey. It must be placed according to its legal format to the product or its data plate. It must be visible, legible and impossible to remove. If a Notified Body was involved in the production control phase, its identification number must also be displayed. It is the manufacturer’s responsibility to draw up and sign an ‘EC DoC’ proving that the product meets the requirements. That’s it, your CE-marked product is ready for the market.

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