Companies that sell their products in Europe do one thing very well. They know exactly how to comply their products with European legislation.
But you are probably wondering: “How can I as an SME sell my products in Europe?”
Well, in this article I will show you how you can make sure that your product meets the European product safety standards. All you need to do is to follow the process as described below. You ready? Let’s do this.
1. Determine which directives apply to your product
CE marking regulates product safety in Europe. The first step towards product compliance is by identifying whether your product is regulated and falls within the scope of CE marking Directives.
Unfortunately, the European Union itself does not provide an explicit list of all CE Directives. A list of the product groups that require CE marking and for which directives exist, can be found on Wikipedia. To determine if a directive applies to your product, you should:
- Google for the product group + directive (for example ‘Electromagnetic compatibility directive’)
- Click on the link of the website of the European Commission, starting with ec.europa.eu/
- Click on the link of the directive (for example (EMC) Directive 2014/30/EU)
- Download the English pdf version of the directive
- Identify under Article 2 Scope, if your product falls under the scope of the directive.
NOTICE Several directives may apply to one product! For example, an electric hair dryer will need to comply with the Low Voltage, EMC and RoHS Directive.
If none of the directives applies to your product, then your product does not need to be CE marked. In that case, the General Product Safety Directive applies, which says that all products placed on the market should be safe.
2. Determine the applicable requirements of the directives
Each directive gives requirements on how a product should comply. These requirements are called the “essential requirements”. You should identify which requirements apply to your product. The requirements are very generic descriptions. To demonstrate that the essential requirements have been met, is by meeting the requirements of applicable harmonised standards.. Standards describe how you can technically comply with the requirements. Although not mandatory, by using standards you create the best possible presumption of conformity.
3. Determine the route to conformity
Although in principle the CE Marking process is a self-declaration process, depending on the classification of your product some directives may require that your products shall be tested and certified by a third-party organization to ensure their conformity. In this stage, you should identify in the directives if your product needs third-party certification.
4. Conduct the product assessment
Now you know which requirements your product should meet, and if you can test yourself or if you need a third party, you need to conduct the actual testing. This testing will be the evidence that your product meets the essential requirements. The assessment should be documented, as this form the basis of your technical file (step 5).
5. Compile the technical file
Besides the product assessment, each directive requires other documents to be part of the technical file. You can find a list of the required documents in the relevant directive. In this step, you are going to collect all documents and compile the technical file. Some examples of what can be required to put in your technical file:
- Description of the intended use
- Test reports
- Drawings, circuit diagrams and photos
- Risk analysis
- Bill of materials
- Design of packaging
- Design calculations
- User instructions
- Copy of the Declaration of Conformity
The technical documentation can be stored electronically or in a paper format and must be held for a period of up to 10 years.
6. Affix the CE marking and sign the Declaration of Conformity
Once the technical file is complete and you know for sure that the product meets all relevant CE Directives, you can draw up the Declaration of Conformity. By signing this document, you declare that the product complies and this you take full responsibility. When signed, you can affix the CE mark to the product.