CE Marking (European Compliance)

‘CE Marking’ is a term commonly used as shorthand for compliance to European product safety or ‘New Approach’ Directives. A valid CE Marking affixed to a product or system by a manufacturer indicates that it meets the ‘essential requirements’ of the applicable Directives and may be placed on the market or put into service anywhere within the European Community (EC) or European Economic Area (EEA).

The ‘New Approach’ Directives resulted from a 1985 agreement between EC Ministers to implement a ‘New Approach to Technical Harmonization and Standards’ in order to ease the free movement of goods within Europe. The Directives, which set out the ‘essential requirements’ in general terms that products must meet, cover a multitude of disciplines.

It is the responsibility of manufacturers both within and outside the EC to ensure that their products, where applicable, comply with the relevant Directives before affixing a CE Marking and placing them on the market in Europe. Failure to do so can result in sanctions such as removal of products from sale or use and in some cases prosecution.

Compliance with European Directives is achieved by applying either specific product safety standards or the Directives’ general requirement during the design and manufacturing of a product. Once a product is placed on the market or brought into service the person within Europe responsible for it must be in a position to demonstrate that the correct standards or Directives have been applied successfully. Product standards, many of which are standardized (harmonized) across the EC are published locally within each member state, whilst the methods by which a responsible person can demonstrate compliance are specified within the Directives.

CE Marking Services from Padmira Consulting

Padmira Consulting specializes in providing support to manufacturers of products that fall within the scope of the following Directives:

  • Medical Devices Directive
  • Electrical Safety (Low Voltage Directive or LVD)
  • Electromagnetic Compatibility  Directive (EMC)
  • Machinery Directive
  • Construction Products Directive (CPD)

Our services include identification of European directives, and this phase may be so complicated, while a single product may be covered by more than one directive. We also help the company by preparation of technical file and changing the management system to cover European standards requirements. Our team of consultant engineers can provide technical expertise to clients on a wide range of product compliance issues. They can identify the most efficient and cost effective route for manufacturers to demonstrate compliance, arrange or undertake testing on behalf of clients and prepare any necessary documentation.

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