Compliance

The manufacturer or supplier should use one of the product conformity assessment modules available within the directive to demonstrate that the product complies with the essential requirements. One of the most common options for product assessment is to apply the relevant standards to the product and/or prepare relevant documentation such as the Technical File. The CE Marking should be affixed legibly and indelibly to the product. The manufacturer should also prepare and sign a ‘Declaration of Conformity.’

Many of the CE Marking Directives include provision for the appointment of Notified Bodies. These are organizations appointed by the Member States in which they are based. Their details are ‘notified’ to the European Commission, who then publish these details in the Official Journal of the European Communities.

The specific functions of Notified Bodies regarding compliance assessment for specific products are defined by the directives. For most, the involvement of a Notified Body is only required for high-risk and safety-critical products.


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