Declaration of Conformity (DoC)
and bring your products safely onto the European market
Certification Experts is your full-service compliance partner and guides you through the complete CE marking process by obtaining the Declaration of Conformity. With over 25 years of experience, our team will help you to obtain the Declaration of Conformity.
Trust our team of experts to compile the Declaration of Conformity for you
EU Declaration of Conformity: Certification Experts as your Globally trusted partner
Before a product can be legally allowed to enter the European market, it has to carry the CE mark. A Declaration of Conformity (also known as DoC) is an official document in which the manufacturer declares that the product concerned complies with the essential requirements of the applicable European directives and/or regulations. The manufacturer must have adequate knowledge of the CE directives and regulation and know how to draw up and to include in a DoC. To do this as quickly and efficiently as possible, it is highly recommended to involve an expert like Certification Experts to guide this process for you.
What is an EU/EC Declaration of Conformity?
A Declaration of Conformity (DoC) is an official certificate in which the manufacturer declares that their product is in compliance with the essential requirements of the applicable European CE Directives and/or Regulations. This document is mandatory as it is necessary to be able to declare compliance with the CE marking. This is also why some people refer to it as the CE Declaration of Conformity, but the EC Declaration of Conformity, EU Declaration of Conformity and Declaration of Performance (DoP) are the official titles for the document. The EC Declaration of Conformity is still used for some older Directives, in the updated/new Directives and Regulations the official name is EU Declaration of Conformity and for construction products it is a Declaration of Performance (DoP). This declaration of conformity acts as signed proof that a product is safe to use. For products that do not fall within the scope of the CE marking, it is not required to compile a declaration, but a voluntary declaration of conformance is recommended.
What is a Declaration of Incorporation and can it replace a Declaration of Conformity?
A Declaration of Incorporation is used when a product is partly complete or designed to be incorporated into another product. It does not and can 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.
Full-service product compliance
Leave it to us.
When is a Declaration of Conformity Required?
When a manufacturer signs a Declaration of Conformity, they declare that the product has been designed and constructed with the appropriate conformity assessment requirements and take full responsibility for its compliance with EU health and safety standards. This includes (but is not limited to) the following product groups:
- Machines and installations (EC Declaration of Conformity)
- Electrical equipment and components (EU Declaration of Conformity)
- Construction products (Declaration of Performance)
- Medical Devices (article 12 EU Declaration of Conformity)
- Personal Protective Equipment (EU Declaration of Conformity)
- Pressure Equipment (EU Declaration of Conformity)
- Radio Equipment (EU Declaration of Conformity)
- Toys (EU Declaration of Conformity)
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).
How do I get a Declaration of Conformity?
Obtaining a Declaration of Conformity is part of the CE marking process, so once you start the process of obtaining the CE mark, assembling the DoC and drawing it up will be a natural part of this process. You can obtain the CE mark and thus the Declaration of Conformity by following 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
- Affix the CE marking and draft a declaration of conformity
Once the CE mark is affixed to the product, it must be supported by the Declaration of Conformity. This must be done for every product that is intended for use within the EEA (European Economic Area) and falls under one or more of the New Approach Directives.
Preparing a Declaration of Conformity: A Practical Example
Drawing up the DoC itself might be difficult if you do not know what to include and what should be left out. The Declaration of Conformity requirements state that all relevant product information must be listed in the document, such as:
- Name/address of manufacturer and responsible Authorised Representative
- Description of product and model number
- Directives and regulations used for the CE marking certification
- List of standards used
- Name and position of authorised person
- Signature and date
All other information depends on what product it is that you want to trade on the EU market. Certification Experts has created DoC templates for all products, so that we can use this to help get your DoC drawn up efficiently and quickly.
Full-service product compliance
Leave it to us.
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.
How do I know 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) and/or Regulation(s).
How Certification Experts can help?
If the Declaration of Conformity is not properly drawn up, contains ambiguous statements, lacks necessary information, or any issue of such matter, it would mean your product would be traded under false safety warranty. This would make it illegal to trade your product in the European Union, meaning that a faulty DoC could have serious consequences for you as a manufacturer. To avoid this, it is best to appoint an expert who can take care of this for you.
Certification Experts has both the knowledge and international experience to help you draw up a suitable EU Declaration of Conformity for your product. We will help you:
- Determine specific Declaration of Conformity requirements
- Determine applicable directives, regulations and legislation
- Collect all necessary product information
- Draw up the Declaration of Conformity
We can even manage the entire CE marking process for you, including these DoC services.
Full-service product compliance
Leave it to us.
All the answers you might need!
Obtaining a Declaration of Conformity is part of the CE marking process, so once you start the process of obtaining the CE mark, assembling the DoC and drawing it up will be a natural part of this process.
It’s important to clarify a common misconception: the CE Certificate is distinct from a Declaration of Conformity. Although these documents are interconnected, they fulfill distinct roles within the framework of European Union (EU) product conformity. The CE certificate, typically issued by a Notified Body or accredited testing laboratory (though not obligatory for most products), is an official document verifying a product’s compliance with relevant EU regulations. On the other hand, the Declaration of Conformity is a mandatory self-declaration by the manufacturer for all CE-marked products. Both documents play crucial roles in affirming a product’s adherence to EU standards and eligibility for the CE marking, but they differ in their origins and functions within the broader conformity assessment process.
CE certificates are often issued by Notified Body or accredited testing laboratory, independent organisations designated by EU member states to assess product conformity. Therefore the best way to check the certificate is to contact the Notified Body or accredited testing laboratory to verify the certificate.
The manufacturer or Authorised Representative (AR) bears the responsibility for maintaining the accuracy and currency of information in the Declaration of Conformity (DoC). The contact details of the manufacturer or AR are explicitly stated on the DoC. These contact details serve as a direct means to reach out to the responsible party, allowing you to verify firsthand that the product aligns with the applicable European health and safety standards.
No, the Declaration of Conformity (DoC) and the CE marking are related concepts but not exactly the same.
The CE marking is a symbol that manufacturers affix to their products to indicate that they conform to the essential requirements of relevant European Union (EU) directives. The CE marking allows the product to be legally placed on the market within the European Economic Area (EEA).
On the other hand, the Declaration of Conformity is a document prepared by the manufacturer or an Authorised Representative stating that the product complies with the applicable EU directives and/or regulations and meets the necessary requirements. The Declaration of Conformity is an important part of the CE marking process, and it should be kept on file by the manufacturer or Authorised Representative. This is also why some people refer to it as the CE Declaration of Conformity, but this and the EC or EU Declaration of Conformity are all titles for the same document. For products that do not fall within the scope of the CE marking, it is not required to compile a declaration, but a voluntary declaration of conformance is recommended.
A Declaration of Conformity (DoC) is an official document in which the manufacturer declares that their product is in compliance with the essential requirements of the applicable European Directives. This document is mandatory as it is necessary to be able to acquire CE marking. When a manufacturer signs a Declaration of Conformity, they declare that the product has been designed and constructed with the appropriate conformity assessment requirements and take full responsibility for its compliance with EU health and safety standards.
The EC/EU Declaration of Conformity, often referred to as the CE Declaration of Conformity, is a self-certification undertaken by the manufacturer or their Authorised Representative to confirm compliance with EU regulations. While certain high-risk products may necessitate the involvement of a Notified Body—a third-party organisation designated by an EU member state—to assess conformity to standards and regulations, the ultimate responsibility for issuing the Declaration of Conformity remains with the manufacturer or their Authorised Representative, even in cases where a Notified Body is involved.
Dicover our Succes Stories
Alfa Wassermann
Kurt Spiegel Vice President of Engineering
Confocal.nl
Peter Drent CEO
Bondtech Corporation
Elsa Brown President
Full-service product compliance
Leave it to us.