The fifth article in a six part series on CE marking
A Legal Declaration of CE Compliance
The EU Declaration of Conformity (DoC) is an important part of the product CE marking process. The DoC is a formal document issued by the manufacturer (or authorized representative) declaring that a product complies with the relevant EU directives and requirements.
Essentially, it's a legal statement affirming that the product meets the essential safety, health, and environmental protection requirements necessary for it to be legally placed on the EU market. By issuing the DoC, the manufacturer assumes full responsibility for the product's compliance with EU regulations.
Contents
There is no specific format for Declaration of Conformity. Each directive will specify what should be included for your product.
The following key elements are common to most directives and should be considered necessary elements of any product declaration.
Date of Issue:
The date the DoC is issued is recorded in this section.
Product Identification:
This section should provide a clear and unambiguous description of the product. This typically includes:
Product name
Model number
Serial number (if applicable)
Any other relevant identifying information
It's essential to include enough detail to uniquely identify the product and distinguish it from similar products. Additional information such as product dimensions, weight, or specific technical characteristics may also be included if necessary for clarity. The goal is to ensure that anyone reviewing the DoC can easily identify the exact product being declared.
Formal Declaration:
This section identifies the document as an EU Declaration of Conformity. It also declares that the named product meets the essential requirements identified in the applicable EU directives.
Applicable Directives and Standards:
This section clearly outlines the specific EU directives the product falls under. Additionally, it lists the harmonized standards that have been applied to demonstrate compliance with these directives.
Conformity Assessment Procedure (Optional):
In the case where conformity to the directives is assessed by means other than harmonized standards, such as internal standards or a Notified Body, the conformity assessment procedure should be identified on the Declaration of Conformity.
Issuer Information:
Identifies whether the manufacturer or a representative is the party issuing the DoC.
Manufacturer's Information:
Information about the manufacturer, including:
Name
Address
Contact details
Note: If the declaration is being put forth by an Authorized Representative that is the direct contact for EU authorities and in control of the product technical information, listing the manufacturer on the DoC is optional.
Authorized representative (if applicable):
If using a manufacturers representative, include the following information:
Name
Address
Contact details
Signatory Information:
The authorized signatory representing the manufacturer or authorized representative must sign the DoC. It is important to ensure that person signing the DoC is authorized to represent the manufacturer. This signature signifies their acceptance of legal responsibility for the product's compliance.
DoC Reference Number (Recommended):
While not explicitly mandated, assigning a unique reference number to a Declaration of Conformity (DoC) is strongly recommended for traceability purposes for the following reasons:
Identification: A unique reference allows for easy identification and retrieval of the DoC.
Traceability: In case of market surveillance issues or product recalls, a unique reference can facilitate efficient tracking of affected products.
Auditability: It aids in internal audits and quality management systems.
Additional Considerations
The following should also be considered when drawing up a product Declaration of Conformity:
The DoC must be drawn up in an official language of the European Union.
The DoC must be translated into the language or languages required by the EU country in which the product is sold.
The manufacturer or authorized representative is legally obligated to keep a copy of the DoC readily available for authorities for at least 10 years after the last product unit is placed on the market.
The DoC itself is not a complex document, typically spanning a single page. However, it represents the culmination of the entire CE marking process and serves as a statement to regulatory bodies and consumers that your product has undergone the necessary conformity assessment procedures and meets the safety, health, and environmental requirements established by the relevant EU directives.
References:
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