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Getting Ready for Europe's New EMC Directive

Manufacturers are bracing themselves for the new EMC Directive that goes into effect July 20, 2007. The current Directive, 89/336/EEC is being repealed and replaced by a more refined Directive 2004/108/EC. All organizations that resell, develop or manufacture electronic devices used in Europe have to comply with the new directive from the European Commission, which is accompanied by an atmosphere of more stringent oversight and potential penalties for noncompliance.

The goal of the European Commission in setting new electromagnetic compliance standards is to "ensure compliance across the EEA, entitle all users to equivalent protection, and eliminate unfair competition." According to Jan Coenraads, who gave a workshop in Brussels on market surveillance measures that come into effect with the new EMC Directive, for manufacturers that do not comply, the Commission is willing:

  • To check the production premise of products that appear to be noncompliant.
  • To prevent further noncompliant products from entering the EU.
  • To apply sanctions when necessary.

ACS, a leader in global compliance testing services, has prepared this summary of 2004/108/EC to help your organization comply with the new changes.

Important Changes
The good news is, for the most part, the provisions of the new EMC Directive are administrative and do not affect how you would gain presumption of conformity on products going forward.

  • The harmonized standards route is still the preferred and most typical route to compliance for most.
  • Declaration to the soon outgoing Directive, 89/33/EEC, in some cases is still possible until July 20, 2009 — however all products still in production as of July 20, 2009 must be compliant to the provisions of 2004/108/EC (the new EMC Directive). Important changes include:
  • More responsibility for manufacturers. There is a renewed emphasis on the fact that the responsibility of a compliant product rests squarely on the shoulders of the manufacturer or his authorized representative. (See "Notified Bodies.")
  • Increased surveillance. Market surveillance will be stepped up under the new directive, with stiffer penalties for manufacturers that do not comply.
  • New clause: notified bodies. Competent Bodies who used to be required for the Technical Construction File, or TCF, conformity assessment procedure will go away in favor of Notified Bodies. (A TCF and a review by a Competent Body was required if harmonized standards were not applied or applied only in part.) Under the new directive, the role of a Notified Body is now voluntary. 2004/108/EC gives more latitude to a manufacturer to be able to self declare compliance without obtaining a presumption of conformity through normal conformity assessment procedures such as applying harmonized standards. A TCF is still required to be completed in these cases, however it is not required to be submitted for review by a Notified Body.
  • New requirements for fixed installations. Fixed installations are defined as a combination of equipment that is assembled at a predefined location and is usually a unique device (such as a large machine) that would likely not be sold commercially. Because of the uniqueness of these types of systems, conformity assessment is not required for fixed installations nor are they required to be CE marked or a declaration of conformity drawn up. However the system should technically be compliant and in fact, will have to be compliant in the case that it is found to be an EMC nuisance.

Five Steps to Complying
  • In regards to how the changes affect past, current and future products, care should be taken before simply re-declaring compliance of your product line to the new Directive. Divide your product mix into three categories:
    a. Products that are still in development.

    b. Those that are in production and have been declared compliant to the current 89/336/EEC Directive but will be obsolete by July 20, 2009.

    c. Those that are in production and have been declared compliant to the current 89/336/EEC Directive and are likely not to be obsolete by July 20, 2009.

  • Products that are in development now should be evaluated to the latest product standards and declared to the provisions of 2004/108/EC the new Directive — no exceptions. For products still in development, the new Directive does not technically change how you gain and declare conformity. Draw up your declaration of conformity to the new Directive for all new products moving forward.
  • Products that have already gone through conformity assessment and have been declared to 89/336/EEC but are likely to be obsolete by July 20, 2009 do not need to be updated. The declaration to 89/336/EC is still valid through July 20, 2009. These products are grandfathered into the new Directive.
  • Products that have gone through conformity assessment and will still likely be in production on or after July 20, 2009 need to be re-declared to 2004/108/EC. Before doing so, a review of the product standards applied at the time of the declaration should be done. If any of the product standards have been revised since the declaration, then a review to the newest version is in order, and it may or may not require new testing.
  • For more information, visit the European Commission's information site at : and

Compliance Consultation
The testing and compliance experts at ACS are experienced in working with European as well as domestic manufacturers, and include among their clients Assa Abloy in Sweden, FATS (Meggitt) in England, and Itron in France, as well as dozens of USA-based manufacturers. Recently, working on the In-Cabin Wireless Access Points that Boeing installs on aircraft around the world, ACS provided certification services that resulted in approval in over 50 countries, including the 35 EU countries.

For more information, contact: Advanced Compliance Solutions, Inc., 5015 B.U. Bowman Drive, Buford, GA 30518 770-831-8048 fax: 770-831-8598 E-mail: Web:

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