When to use it?

For most equipment, there is a self-certification route to compliance. Broadly, this involves ensuring equipment complies with certain harmonized European Standards, ensuring that this compliance can be demonstrated, and then compiling the requisite documentation and certification.

Often, CE Marking directives require certification of quality management systems to ISO 9000 standards.

The following are excerpts from a CE informational pamphlet issued in April of 1997 by the National Institute of Standards and Technology (NIST), The U.S. Department of Commerce and Dr. S.I. Warshaw

How to use it?

There are about 30 Directives, either adopted or under consideration, which require that products be marked with the CE mark. More than one Directive can apply to many given products.

• Identify all applicable EU Directives (laws)
• Assess your product to the "essential requirements" contained in the Directives.
• Choose the appropriate conformity assessment module (Fig. 1); i.e., self certification or manufacturers declaration under Module A, or one of the other modules where the use of third parties is required.
• Determine the applicable standards, international, European or national.
• If required, choose a "competent body" in the U.S. to perform test on products (an updated list is maintained by the U.S. Department of Commerce).
• If desired, choose an authorized representative for your company in the EU.
• Prepare a technical file, including a users manual, particularly for products with high risk hazards.
• Assemble the required approvals and certificates and prepare a Declaration of Conformity for each applicable Directive. Declarations of Conformity and technical files can be maintained in English.
• Affix the CE mark in accordance with the laws (the format of the CE mark and its proper location is described in Directive 93/44/EEC, dated 1 January 1997.)
• These are excerpts from a CE informational pamphlet issued in April of 1997 by the National Institute of Standards and Technology (NIST) along with other departments.

Availability:

For US Businesses:

The Department of Commerce's International Trade Administration and Technology Administration can assist any U.S. manufacturer by providing them with:

• Office of European Union and Regional Affairs
  International Trade Administration
  Herbert C. Hoover Building, Room 3036, Washington DC 20230
  Ph: (202) 482-5276 Fax: (202) 482-2155
  Email: ludolph@usita.gov

• U.S. Mission to the EU
  40 Boulevard du Regent, B-1060 Brussels Belgium
  Ph: (32) 2/508-2674 Fax: (32) 2/513-1228
  Email: hdavis@doc.gov

• National Center for Standards and Certification Information
  NIST North, room 164, Gaithersburg MD 20899
  Ph: (301) 975-4040 Fax: (301) 926-1559
  Email: j.overman@nist.gov

• Reference to the harmonized standards in the context of the 'New Approach' Directives list of standards published in the Official Journal of the European Community at the date of January 1996. http://www2.echo.lu/nasd/

• American National Standards Institute
  11 West 42 Street, 13th Floor, New York, NY 10036
  Tel: (212) 642-4900 Fax: (212) 302-1286
  E-mail: info@ansi.org Internet: http://www.ansi.org

For European Businesses:

• European Organization for Testing and Certification
  A focal point European Conformity assessment activities
  http://www.eotc.be/

What are directives?

Directives are the mechanism by which European-wide legislation is enacted.

Directives are issued from Brussels (after consultation and agreement by member states). These are then adopted by each state by the incorporation of corresponding legislation according to their own national legal framework.

EC Directives are issued covering a whole host of matters, however of particular relevance are certain Directives known as the 'New Approach Directives'. These are a set of Directives which serve two primary purposes.

• Firstly, they ensure that all products which are covered by them are safe, by specifying requirements, (principally safety related) which the products must meet.
• Secondly, they provide a 'level playing field' for products within Europe, by the introduction of a single market. All products which meet all the requirements of the directives may be freely marketed anywhere within the European Economic Area without further approvals being required.

Special thanks to Dr Harry Angelopulos, Unicon, Athens, Greece for suggesting this topic