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I have been selling my product for years, and no one has ever complained about it interfering. Why is the European Union (EU) requiring all this testing and compliance documentation for EMC? Isn't it really a trade barrier?
The EMC Directive and other CE Marking Directives apply to all manufacturers of products affected by the individual directives. This includes manufacturers within the EU. The New Approach Directives came about as a means to reduce barriers to trade. Prior to these New Directives, each country in the EU imposed obligations on business in the interests of safety, consumer protection, etc. They, in turn, were barriers to trade because of the different requirements in different countries. The New Approach Directives provides a common harmonized approach to the essential requirements of each country.
You can test anywhere you wish as long as the equipment, capability and expertise exist to produce test results according to the requirements of the International Harmonized Standards produced by CEN and CENELEC, identified by the designation EN. Technology International has established a network of Test Laboratories which have all been assessed under the guidelines of ISO Guide 25, the international standard for test facilities, and can ensure competent testing.
The CE Marking is a certification marking of products sold within the EU. This one mark supersedes all individual national marks of countries in the EU and symbolizes that a product has met all applicable 'New Approach' Directives. The 'New Approach' Directives are product and/or industry specific and address issues such as Electromagnetic Compatibility (EMC), Product Safety, Medical Devices and several others.
How do I demonstrate compliance with the EMC Directive?
The requirements of the EMC Directive state that the product must not generate a level of disturbance which prevents radio and telecommunications and other apparatus from operating as intended and must have a level of immunity to enable it to operate as intended.
There are two routes available; either by completing an 'EMC Assessment' of the product and compiling documentary evidence in a Technical File, or by testing in full to the EMC Harmonised Standards as published in the Official Journal of the European Union (OJEU).
When should I use the Technical File Route to demonstrate conformity?
Generally, Technical Files can be used to demonstrate conformity for the following reasons:
How do I know an EMC Assessment is adequate?
You don't. If an EMC Assessment has been completed by ensuring a product passes tests to 'harmonised standards' (i.e. the Standards Route) it is normally assumed that this demonstrates conformity with the requirements of the Directive. This may not however, be true in all circumstances. Having a Notified Body conduct a formal review of the supporting documentation for an EMC Assessment will provide definitive confirmation of its adequacy.
The purpose of a Notified Body is to help the manufacturer (or his authorised representative within the Community) ensure that their products meet the essential requirements of the EMC Directive by reviewing the technical documentation that has been drawn up. It is an important and valuable service, which reduces the risk of a manufacturer's claim of conformity being challenged at a later date.
When should a Notified Body be used?
A manufacturer may voluntarily choose to employ a Notified Body to review Technical Documentation in order to give additional confidence to a claim of conformity to the EMC Directive. Alternatively a manufacturer's customers or the relevant regulatory authorities may make a review of Technical Documentation by a Notified Body mandatory for specific products or types of product.
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