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Application of Standards

Depending on the product type there may be a number of routes to demonstrating compliance with EU Directives.

For the majority of products that require CE marking a 'harmonised' standard may exist.  The use of the standards is the simplest and lowest risk route to compliance.  There are several levels of standards that exist and their use appears below in order of preference:

• A European harmonised standard (EN) published in the Official Journal of the European Union (OJEU)
• An IEC standard that has been published where an EN standard does not exist
• A national European Union standard where neither of the above exists
• A Code of Practice where all of the above do not exist

Note however that there are significant differences between US and European standards and US standards which are not listed in the OJEU cannot be used.

Having identified the appropriate standard the manufacturer may have one or more options to follow:

Self–Declaration

This is applicable for products that do not require mandatory third party examination.  This route allows the manufacturer to follow an internal set of controls through product assessment and testing.  Under self-declaration the manufacturer takes full responsibility for all aspects of the process. Eurolink (Europe) will be pleased to help you achieve compliance or provide additional information as to how this can be achieved.

Voluntary Certification

This is a hybrid route where the manufacturer conducts its own testing and then applies to an EU approved ‘Notified Body’ for ratification of the testing and documentation.  Eurolink (Europe) will be pleased to provide this service for the following Directives:

• EMC Directive
• Machinery Directive
• Low Voltage Directive
• Radio and Telecommunication Terminal Equipment Directive

Mandatory Certification

This route applies primarily to higher risk equipment such as some types of medical devices, it is a possible route for some high risk machinery where harmonised standards have not been applied.  In such cases compliance is achieved through use of the services of a Notified Body and the following procedures will be followed:

• Assessment and categorisation of the general product to be certified.
• Determination of the ‘environment’ in which the product will perform.
• Testing to demonstrate the products performance against any relevant standards or essential requirements.
• The writing of a Technical File or Technical Construction File.
• Formal assessment by a Notified Body.
• Certification.

Eurolink (Europe) will be pleased to provide further advice on this route to demonstrate conformity.  For further information please Contact Us.