Background to CE Marking

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Background to "CE" Marking

From the start of the European Union the aim was to reduce barriers to trade. One of the most significant barriers was the large number of National Standards which applied to a very wide range of products. Under the “New Approach” directives, CE Marking was introduced as a common product requirement for an expanding range of products.

 

“New Approach” Directives. In 1993 the European Commission issued a combination Directive which introduced CE Marking requirements to a wide range of products. This Directive amended several product specific directives and, thereafter, the range of product specific directives has grown. In addition there are some more general CE directives such as for Electro-Magnetic Compatibility compliance.

 

Principles of CE Marking. Each directive has two major components:

  1. The routes to compliance and the
  2. Essential Health and Safety Requirements which have to be met.

The routes usually depend on the severity of the hazards that the particular product might involve. Many different routes are offered to provide manufacturers a choice, but the most common are full quality assurance from design to operation in the field and, for lesser hazards, self declaration that the product meets the essential requirements of the applicable directives. The Essential Requirements have been agreed by all the nations of the European Community and are mandatory.

 

The CE Mark. The CE Mark is the most widely accepted mark in the world. By compliance, you open the doors to a market of some 500 Million consumers in 25 countries. Should you need assistance: contact Atlantic Bridge Ltd.

 

Can you afford to ignore this opportunity?

 

Help is at hand

For further information and guidance on the best approach for your products including the required advice on the assembly of a technical file, conduct of the necessary risk assessment, and implementation of ISO9001 or ISO 13485 why not call our experts.