CE Mark, the

For all current applicable directives for the CE mark, the following website can be consulted ... 

Manufacturer is the entity responsible for designing and manufacturing a product that is covered by a directive or directives with a view to placing it on the market. The manufacturer shall follow the appropriate assessment procedures and is responsible for all aspects of the product s conformity. This includes, but is not limited to, the product s design, testing, reports, documentation, declaration, technical file, and CE marking. The manufacturer is ultimately liable for the product s... 

CE marking is the manufacturer s or supplier s self-declaration symbol to indicate that the product has undergone all the necessary evaluation procedures and is in conformity with the minimum requirements of the relevant directives. Products that conform to all the applicable directives and standards may bear the CE marking. The CE symbol is not a registered trademark and is, in principle, under the manufacturer s control. Products bearing the CE marking may be placed on the market. 

Directives issued before 1985 are considered Old Approach directives except when amended after this date, as is the case for the Low-Voltage Directive (LVD) 73/23/EEC, amended by 93/68/EEC adding the CE marking. The LVD is valid under the New Approach. 

Technical file. The manufacturer s technical documentation file supports the CE marking. The contents of a technical file generally include the declaration of conformity, name and address of manufacturer, product description and identification, list of standards and directives applied, design and schematic drawings, calculations, test reports, parts lists, manuals, and so on. Technical files must be readily available and may be requested by enforcement authorities for inspection purposes should a product become suspect or an incident occur. 

The release procedure is defined following almost exactly the correspondence process of ISO 62304 in case the version is an official main release, and especially if it is to be submitted for approval of a regulatory body (typical FDA 510(k) clearance or CE mark), the overall residual risk is to be evaluated and documenting it takes into account the verification and validation of risk mitigations and the remaining open risks. 

Since all products subject to New Approach Directives carry CE marking, the marking is not intended to serve commercial purposes. 

The Regulations have requirements relating to the application of a CE mark, the generation and retention of a technical construction file containing prescribed information, and the drawing up of declarations of conformity or... 

Employers must ensure that work equipment conforms to current EU standards and requirements. Most new work equipment particularly any machinery must display the European CE mark. The CE mark is merely a claim by the manufacturer that the equipment meets all relevant standards and is safe. 

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