A Declaration of Conformity (DoC) is mandatory for all products covered by one or more ‘CE marking’ directives. In this guide for importers and Amazon sellers, we explain how to create a DoC, associated costs, relevant products and much more.
What is a Declaration of Conformity (DoC)?
The Declaration of Conformity is a self-issued document ‘declaring’ that a certain product is compliant with certain product directives and standards. This information is normally included:
- Product identification/SKU
- Product features
- Name and address of the manufacturer/importer
- List of EN standards and/or EU directives
- Responsible individual
The exact information can be found in the relevant directives or regulations. That said, the DoC must be supported by a test report and technical file.
Further, the DoC is normally issued on a ‘per product basis’. As such, you need to create one DoC per product. The DoC must also be updated in case additional regulations or standards are added in the future.
Which products require a Declaration of Conformity?
The Declaration of Conformity is mandatory for all products which must be CE marked. As such, the Doc is part of the CE marking process.
Here are some examples of products for which a DoC is required:
- Medical devices
Examples of CE Directives:
- RoHS Directive
- Low Voltage Directive
- EMC Directive
- Radio Equipment Directive
- Toy Safety Directive
- Personal Protective Equipment Directive
- Medical Devices Directive
How do I get a Declaration of Conformity?
Here are a few different ways to obtain a Declaration of Conformity:
Create it yourself: Information about what to include in your DoC is available on the official EU website – as long as you know which directives and regulations apply to your product. That’s often the hard part. You can also contact consumer product safety authorities in EU countries and ask them for guidance on applicable regulations and what information you’ll need to include in your DoC.
- Step 1: Confirm mandatory regulations
- Step 2: Confirm required DoC information
- Step 3: Create your DoC
- Step 4: Print and sign the DoC
Consultants: INSTRKTIV and other consulting firms can help you create a DoC from scratch. All you’ll need to do is to sign and you’re done. Most consultants charge from a few hundred EURs and up.
Online Services: Product IP and CE-check.eu provides online platforms, helping importers and manufacturers create DoCs with relative ease. You can also buy DoC templates from various websites.
Are importers responsible for issuing the DoC?
The DoC can either be issued by a manufacturer or an importer. However, in most cases, the importer is considered as the manufacturer in the following scenarios:
- You import custom-designed products from a manufacturer outside the EU
- You import private label products from a manufacturer outside the EU
Can I get a Declaration of Conformity from my supplier?
Most manufacturers in China, and other countries outside the EU, don’t have the experience or expertise to issue a correct Declaration of Conformity. In short, they simply don’t know how to create a DoC.
Importers and Amazon sellers should not rely on their suppliers to issue a DoC. Also, keep in mind that a Declaration of Conformity is not the only document you need when importing CE marked products to the EU.
Do I need a Declaration of Conformity for selling on Amazon?
Amazon requires that products sold on its platform comply with the national regulations and standards. As such, sellers of electronics, toys, sunglasses and other ‘CE products’ must provide a DoC.
Amazon often requests additional information:
- Declaration of Conformity
- Test report
- CE mark product images
Further, Amazon doesn’t accept any DoC at face value. Your Doc is likely to be rejected if it doesn’t include the required information.
How much does it cost to get a Declaration of Conformity?
It doesn’t cost anything to self-issue a Declaration of Conformity. That said, costs arise if you intend to get help from a consultant, buy a template or use an online service.
Here are a few DoC cost examples:
- Consultant: 500 EUR
- Online Service: 100 – 300 EUR
- Template: 50 – 150 EUR
What’s the difference between a test report and a DoC?
A DoC is essentially a ‘compliance statement’. The DoC itself doesn’t prove that the product is compliant with the requirements outlined in applicable directives and regulations.
Test reports, on the other hand, list applicable standards, tests, procedures, and results – which in turn supports the statements on the DoC.
That said, a test report is not a replacement or substitute for a DoC.
Do I need to send the Declaration of Conformity to the customs authorities?
The DoC is generally not part of the customs documentation. That said, the customs authorities can request a DoC upon entry in an EU member state.
What can happen if I don’t have a Declaration of Conformity?
Consumer product safety authorities in EU countries can request a Declaration of Conformity at any time. They may contact you weeks or even months after you’ve started selling a product.
Failing to provide a Declaration of Conformity often results in fines and sales ban – meaning that you cannot continue selling your product.
As mentioned, Amazon may also suspend your product listings.
In short, make sure you have your Declaration of Conformity in place before you start importing and selling CE products in the EU.