What is an EU/EC Declaration of Conformity?
A Declaration of Conformity (DoC) is an official certificate drawn up by the manufacturer or their authorised representative. It is a mandatory document prescribed by most of the European directives and regulations. The DoC declares that a product is in compliance with all relevant European product safety requirements. For information on what information a Declaration of Conformity entails, click here.
When is a Declaration of Conformity Required?
All products bearing the CE marking must have a Declaration of Conformity. This includes product groups such as:
- Machines and installations
- Electrical equipment and components
- Construction products
- Medical Devices
- Personal Protective Equipment
- Pressure equipment
- Radio equipment
If you are unsure whether your product requires CE marking, you can find out more about which countries and areas accept the CE mark here.
How do I write a Declaration of Conformity?
Drafting a Declaration of Conformity is an important part of the CE marking process. It is the final step before affixing the CE mark to your product. Before writing the Declaration of Conformity, you must have carried out these steps:
- Identify the EU requirements for your product
- Check whether your product meets the specific requirements
- Check whether your product must be tested by a Notified Body
- Test your product
- Compile the technical dossier
As a manufacturer, it is your responsibility to draw up a Declaration of Conformity and to ensure that it includes all of the necessary information. If you need help drafting your DoC, our experts are happy to help.
How do I know whether a Declaration of Conformity is valid?
It is the responsibility of the manufacturer or Authorised Representative (AR) to ensure that the information provided in a Declaration of Conformity is relevant and up to date. The contact information of the manufacturer/AR is indicated on the DoC. You can use this information to take up contact with the responsible party directly to ensure that the product meets all relevant European health and safety standards.
In many cases, products must meet multiple EU harmonised standards. This is especially the case for products which consist of many parts (such as machinery) and for medical devices. If you need help identifying whether a Declaration of Conformity is valid you can contact us. We can help you verify that the DoC meets and mentions all relevant standards and necessary testing procedures to ensure that it meets the legal requirements of the applicable Directive(s).
Is a CE certificate the same as a Declaration of Conformity?
Sometimes a Declaration of Conformity is referred to as a CE Statement or CE certificate. This is because the DoC is the official document that states that a product meets all EU health and safety requirements and can therefore legally bear the CE mark. However, the formal name for the document is the Declaration of Conformity.
What is a Declaration of Incorporation and can it replace a Declaration of Conformity?
A Declaration of Incorporation is used when a product is incomplete or designed to be incorporated into another product. The Declaration of Incorporation states that the product is incomplete and can therefore not be CE marked. However, it does not replace the Declaration of Conformity. The manufacturer of the final product is responsible for drafting a Declaration of Conformity and applying the CE mark before making the product available to a consumer.
How long should a Declaration of Conformity be kept on file?
The manufacturer or Authorised Representative must keep the Declaration of Conformity on file for ten years from the date that the product is placed on the market (unless otherwise mentioned in the applicable Directives).
Where can I find a Declaration of Conformity template?
The EU directive(s) relevant to your product will mention all of the information that your Declaration of Conformity needs to include.
Do you have more questions about the EU/EC Declaration of Conformity? We’re here to help. Our experts can help you draft a Declaration of Conformity and determine whether a product’s DoC mentions all relevant standards and testing procedures. We also offer services as an EU Authorised Representative.