What is a Declaration of Conformity?
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.
Contents of the Declaration of Conformity
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:
- Name and business address of the product manufacturer or the authorised representative.
- Identification that allows the product’s traceability. E.g. a serial or model number, or type identification.
- Notified body details, if applicable.
- A statement, saying that the manufacturer takes full responsibility for the product’s compliance.
- A list of all applicable CE directives and regulations the product complies with.
- A list of all EN harmonised standards or methods used for verifying the product’s compliance with the directives.
- Name and signature of the manufacturer.
- The place and date of issuing the DoC.
- Any additional information.
Here is an example of a very simple DoC.
Who can issue and sign a Declaration of Conformity?
The Declaration of Conformity can be issued and signed by the person that places the product on the European single market. In most 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 EU 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.
What products need a DoC?
A product needs to have a Declaration of Conformity if it falls within the scope of at least one of the following product groups:
- Lifts and cableway installations
- Construction products
- Electrical equipment
- Radio equipment
- Energy-related products
- Equipment used in explosive atmospheres
- Pyrotechnical articles
- Gas appliances
- Weighing instruments
- Measuring instruments
- Medical devices and in-vitro medical devices
- Implantable medical devices
- Outdoor equipment with noise emission
- Personal protective equipment (PPE)
- Pressure equipment and pressure vessels
- Products containing hazardous substances
- Recreational craft
- Water boilers
How to create a Declaration of Conformity?
The following four steps should help anyone with experience in CE marking to draw up their Declaration of Conformity:
- Select a relevant product group on the website of the European Commission.
- Read about the Declaration of Conformity in the content of each applicable Directive.
- Draw up the DoC.
- Recheck if the Declaration of Conformity you’ve drawn meets all the requirements.
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 should use the help of professionals. Get in touch with our team to get a valid Declaration of Conformity.
Common mistakes often found in the Declarations
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:
- The title of the document is a certificate, instead of a declaration.
- It says ‘CE declaration’ instead of ‘EU declaration’.
- An incomplete list of all relevant standards and directives.
- A signature is missing
- The DoC lacks a statement of conformity.
- The person signing the DoC doesn’t work or have an appropriate position in the company.
- The date of issue predates some of the standards or directives stated
- The Declaration of Conformity is misleading or creates confusion (e.g. it contains a list of irrelevant standards)
- The product has a serial number, but the same isn’t stated in the DoC.
- Not all standards have correct numbers with prefixes.
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] or check what else we can offer:
- regulatory compliance management system for enterprises
- supplier compliance software for meeting SCIP requirements
- CE marking of medical devices (complete assistance)
- Electrical safety testing and certification
- EU authorised representative services for non-EU manufacturers