The Declaration of Conformity is a legal document which needs to be completed for all CE Marked products sold in the European Union with few exceptions. The Declaration of Conformity document needs to include the following:
- Name/address of manufacturer (and of responsible person where applicable)
- Model and/or serial number of equipment
- List of relevant directives
- List of standards used, with dates + amendments
- Declaration statement
- Notified body details (if required)
- Name and position of person signing
Conformance has assisted thousands of companies through the CE marking process and helped them produce a Declaration of Conformity to accompany their products.
Detailed information on the Declaration of Conformity
The Declaration of Conformity is a legal document which the manufacturer or authorised representative signs to state that the product meets all of the requirements of the applicable EU directives and regulations.
The Declaration of Conformity allows an enforcement authority to identify who is responsible for a product and the activities that person claims to have done to CE mark it. In making a senior person put their signature on a piece of paper, it concentrates their mind on whether or not the product really does comply and therefore makes compliance more likely.
The Declaration of Conformity must be issued by the “manufacturer” or their “authorised representative”. However, this is not necessarily the person or company who actually made the product. According to The New Legislative Framework (NLF) Commission Decision 768/2008/EC (Recital 26) "Any economic operator that either places a product on the market under his own name or trademark or modifies a product in such a way that compliance with applicable requirements may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.” Effectively, if you re-brand a product or modify it such that safety might be affected, you become the manufacturer and should issue a Declaration for the ‘new’ product. This includes importing a product from outside the EU that was not CE marked by its original manufacturer.
Test houses and Notified Bodies do not issue a Declaration of Conformity because they do not have overall responsibility for the product. They issue certificates stating their opinion about limited aspects of conformity.
The manufacturer does not need to be based in the EU, but certain Directives require an EU-based contact point to be identified to act as a contact point for the EU authorities (e.g. the Machinery Directive; see below).
The NLF directives require a single Declaration of Conformity document for all of the applicable directives. They specify a consistent format and content of the Declaration of Conformity in a “model structure” with the items numbered as listed below. This is to make Declarations of Conformity easier to understand, especially if they are in another language or alphabet:
1. The unique identification of the product
2. Name and address of manufacturer or authorised representative taking responsibility for the product
3. The statement “This declaration of conformity is issued under the sole responsibility of the manufacturer”;
4. Description of product allowing traceability;
5. The declaration of conformity statement: “The object of the declaration described above is in conformity with the relevant Union harmonisation legislation” with a list of the applicable CE marking directives and regulations the product complies with;
6. Details of the standards if any have been applied;
7. Details of notified bodies as required in the conformity assessment procedures, their conformity assessment procedures and certificates; (e.g. for product type approval or quality system assessment.). Notified Body involvement not specified in the directives should not be declared.
8. Any additional information;
The signature of the senior person representing the manufacturer or authorised representative.
The Declaration of Conformity must be translated into an official languages of each EU member state where the product is placed on the market.
Directives that predominantly apply to professional equipment require the Declaration of Conformity to be supplied with the product. (e.g. Machinery Directive, ATEX Directive, RED (Radio Equipment Directive) Those predominantly for consumer equipment do not (e.g. Low Voltage directive, EMC directive.) This reflects the end users interest in the Declaration of Conformity.
Some directives require special additional information on the Declaration of Conformity:
|2000/14/EC||Noise Emissions of Outdoor Equipment Directive||Sound power level|
|2009/48/EC||Toy Safety Directive||Colour image of the toy|
|2014/34/EU||ATEX Directive||ATEX marking code|
|2013/29/EU||Pyrotechnic Articles Directive||Registration number|
|2014/53/EU||Radio Equipment Directive (RED)||Description of accessories, components and software|
|2014/68/EU||Pressure equipment Directive (PED)||Description of the pressure equipment constituting the assemblies and their conformity assessment procedures|
|2006/42/EC||Machinery Directive||Name and address of EU contact point|
The Machinery Directive’s additional information is worthy of special mention. The Declaration of Conformity must identify the name and address from where the EU authorities can obtain the technical documentation for the product and this must be an address in the EU. Manufacturers outside Europe may find our DocEUpoint service to be useful in helping them to fulfill this requirement.
In July 2021 a new regulation on market surveillance and compliance of products (EU)2019/1020) will apply to most other CE marked products and alters the obligations for the various economic operators to be within the community. As such, our DocEUpoint services will be expanding to incorporate these changes.