When I tell people that I’m always the first person to examine the EU Declaration of Conformity when purchasing new products, I get irritated looks. Is reading a Declaration of Conformity an occupational disease?
As a Consultant on CE-related issues, I must repeatedly conclude that many manufacturers have problems with the legal classification of their products, and they actually don’t know exactly what an EU Declaration of Conformity is and what is involved with issuing one.
What is a Declaration of Conformity?
A Declaration of Conformity is generally a written confirmation from the individual(s) responsible that the specified characteristics have been complied with and are fulfilled. For example, a manufacturer, dealer, or service provider indicates that their product or service contains the characteristics specified in the Declaration of Conformity.
What is an EU Declaration of Conformity?
In order to harmonise the European Community market, the EU provides legally binding characteristics for certain products.
In the EU Declaration of Conformity, the manufacturer confirms that a product it has placed on the market complies with the essential health and safety requirements of all relevant European Directives and Regulations. The manufacturer declares that its product complies with legal requirements.
What do I need for an EU Declaration of Conformity?
In order to issue an EU Declaration of Conformity, the manufacturer must first carry out a conformity assessment procedure. So the manufacturer must:
- Identify which EU harmonisation legislation applies to its product
- Fulfil all requirements
- Demonstrate conformity
For machines this means, for example:
- Comply with all basic health and safety requirements, in accordance with Annex I of the Machinery Directive
- Create a risk assessment
- Create an operating manual
- If necessary, translate into the local-language (or local languages) where the machine is in operation.
- Provide technical documentation, in order to assess compliance of the machine with the requirements of the Directive:
- Descriptions of the machine, overview drawings, wiring diagrams; explanation of operation, complete detailed drawings, calculations, test results, certificates, applied standards; all technical reports with test results, a Declaration of Incorporation and installation instructions for installed incomplete machines, a Declaration of Conformity and operating instructions for installed machines
The EU Declaration of Conformity completes the "CE Process". After the signature, the CE Marking for the product can be done.
What is the content of the EU Declaration of Conformity?
Each EU Directive sets the minimum content of the EU Declaration of Conformity for its scope. This includes information about the manufacturer, the identification of the product, the relevant harmonisation legislation, the harmonised standards applied, the participation of involved bodies, and a declaration by the manufacturer of compliance with all requirements.
The EU Declaration of Conformity is signed on behalf of the company. The location, date, name, and function of the undersigned must be specified.
The Declaration of Conformity is therefore an important means of communication between the manufacturer and its customers: The manufacturer not only fulfils its statutory duty, but can also demonstrate its competence and therefore create trust in the product with the customer. For me, as a purchaser of a product, reading this Declaration is not just an occupational disease...
A sample Declaration of Conformity, as well as additional details on CE Marking, can be found (after entering your login credentials) on our smart space.
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