The EU Declaration of Conformity (DoC) is a legal document, wherein a manufacturer formally declares the compliance of a product with the essential health, safety and environmental requirements of the relevant directives. By drawing up and then signing the EU Declaration of Conformity, the manufacturer assumes full responsibility for the product’s CE compliance. The DoC is drawn up only after the technical documentation (aka technical file) is compiled.
The Declaration of Conformity is mandatory for any product that falls within the scope of the CE marking legislation. In most cases, when a product is covered by several product safety directives, only a single DoC needs to be drawn up.
A copy of the Declaration of Conformity should be added to the technical file and made available upon request of the national market surveillance authorities. If the Declaration isn’t available or is invalid, the market authorities will recall the product, issue a monetary fine and the person who placed the product on the market could face imprisonment.
The Declaration of Conformity must be kept for ten years from the date of placing the last product on the market unless the relevant CE directives provide for any other duration.
The DoC must be drawn up in one of the official languages of the European Union. However, the CE directives don’t necessarily specify who has an obligation to translate it. Logically, this should be the person making the product available on the EU single market.
Most CE directives and regulations have different requirements for the content of the Declaration of Conformity. However, the format and content of the Declaration of Conformity should follow a “model structure” to be easier to understand, especially if it’s in another language or alphabet. The DoC usually includes the following elements:
Here is an example of a very simple DoC.
The Declaration of Conformity can be issued and signed by the person that places the product on the European single market. In most of the cases, this person is the product’s manufacturer or importer.
When a product is imported into the EU/EEA from a non-EU country, the importer must make sure that the product complies with all legal product safety requirements. Moreover, the importer is also responsible for verifying that the technical file is correctly assembled and available.
Distributors don’t need to draw up the DoC but must verify that the manufacturer or importer has taken all legally required measures. However, if a distributor decides to rebrand or modify a product, they should take over the manufacturer’s responsibilities. Thus, draw up and sign a Declaration of Conformity.
The manufacturer’s authorised representative can also sign the DoC. The authorised representative must be based in the EU/EEA and be explicitly designated by the manufacturer in the non-EU country.
The declaration can never be issued by a Notified Body or a test house because they don’t have overall responsibility for the product’s compliance. They can only issue test certificates stating their opinion about limited conformity aspects.
A product needs to have a Declaration of Conformity if it falls within the scope of at least one of the following product groups:
The following four steps should help anyone with experience in CE marking to draw up their Declaration of Conformity:
However, if the person has never dealt with the CE marking process, there is a high risk of getting it wrong. So, importers and manufacturers with zero experience in CE marking are advised to use the help of professionals. Visit the product compliance hub to get help with the Declaration of Conformity.
Although the layout of the Declaration of Conformity is fairly straight forward, it’s easy to make mistakes in the detail of its content. Even a single error can invalidate the Declaration of Conformity. The following list includes some of the most common mistakes found in the DoCs:
All of these simple mistakes are easily avoidable by paying a bit more attention to what the relevant product safety directives state and staying up to date with the changes and updates in the standards.
If you need assistance with your Declaration of Conformity or other aspects of CE marking, get in touch with Clever Compliance’s team of experts at [email protected].
Visit Clever Compliance