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Thursday, June 24, 2010

the CE Marking process

How do I obtain CE Marking for my product?
There are a series of steps outlined below, depending upon your product and the nature of the risks it presents:
1Determine if any directives apply to your product. If more than one applies you will have to comply with all of them.
2Determine the extent to which your product complies with the essential requirements for design and manufacturing in the applicable directive(s).
3Choose the conformity assessment procedure from the options (modules) called out by the directive for your product. There are several modules available for the Conformity Assessment Procedures as listed below:
Module A: internal production control
Module Aa: intervention of a Notified Body
Module B: EC type-examination
Module C: conformity to type
Module D: production quality assurance
Module E: product quality assurance
Module F: product verification Module G: unit verification
Module H: full quality assurance
The directives often use a series of questions about the nature of your product to classify the level of risk and refer to a chart called "Conformity Assessment Procedures". The chart includes all of the acceptable options available to a manufacturer to certify their product and affix the CE Marking.
Minimal Risk
Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product.
Greater Risk
Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body". This is an organisation that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union. Lists of notified bodies are published by the European Commission in the Official Journal of the European Communities.
A Notified Body is usually able to offer some of the services required: product testing; type examination certificate issue; technical file and design dossier evaluation; surveillance of product and quality system; identification of standards.


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