Step 1: Find the EU-directive(s) and harmonised standards that apply
The European Commission has made directives for product groups that require a CE marking. In the directives, you will find the EU legislation that applies to each product group. In some cases, more than one directive applies to the same product group. For example, electrical and electronic products fall under the low voltage, EMC and RoHS Directive.
The European harmonised standards state the essential requirements per directive in detailed and technical terms. The Netherlands Standardisation Institute (Nederlands Normalisatie-instituut, NEN) manages and develops these standards. To receive the standards on paper or digitally, you can request them on the website of the NEN.
Step 2: Check product specific requirements
Check which EU directives apply to your products and if these standards are met. Products that are produced using the harmonized standards imply a “presumption of conformity”.
You are allowed to use these standards, or to use another option to show you meet the requirements. Make sure also to pay attention to the directives’ regulations on product descriptions and manuals. For instance, product warnings and contact details of the producer or importer.
Step 3. Decide if you need to have an independent conformity assessment
When you apply a directive, you have to get it right. If you are not certain of this, you can have an assessment made by an independent conformity assessment body. You don’t have to make use of a conformity assessment body in every case. In most cases this only applies to products with high safety risks. You can search the NANDO Information System for the notified bodies per country and directive.
Step 4: Test the product and check its conformity
As manufacturer, you are responsible for testing your products and checking that they meet the essential requirements and applicable directives. This is called conformity. An important part of this procedure is the risk assessment. You can conform with the necessary essential requirements of the directives by applying harmonised standards.
Step 5: Draw up the required technical documentation and make it available
You have to draw up technical documentation in which the conformity of your products is stated. Make the documentation available to market surveillance authorities in case of a request. In the technical documentation you include drawings, specifications, test reports, inspection certificates, manuals and a Declaration of Conformity. Keep in mind that the requirements may differ per directive.
If you import goods from outside the European Economic Area, make sure that the foreign manufacturer confirms in writing that he will provide you with the technical documentation when this is requested by a market authority. You have to store all documentation for a minimum of 10 years after the manufacturing date.
Manuals must be written in the language(s) of the country in which the product is sold or consumed. The manual provides users with instructions on the usage of the product, particularly in potentially dangerous situations. Inform users of the inevitable risks when they make changes to the design, or if they use it in the wrong way. The manual’s language and content demands may differ per directive.
Step 6: Put the CE marking on your product and draw up the EU Declaration of Conformity
As a manufacturer, you must ensure that the CE marking is put on the product or its data plate visibly, legibly and indelibly. If a notified body has been involved in the production phase, you must state the body’s identification number on your products. Lastly, you must draw up and sign the EU Declaration of Conformity. By doing so, you take responsibility for the conformity of your products.
You must include the Declaration of Conformity in your technical documentation. For some product groups, you may need to include a proof of this declaration when supplying the products to your customers. You can find further instructions in the directives that apply to your products.
The European Commission provides manufacturers, importers, distributors and consumers with information on CE marking. Here, you can also find out which organisations can help you provide the correct CE marking per country.