There are about 30 Directives of EC, 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.
The CE mark is covered by Council Decision 93/465/EC. Annex B(d) gives these guidelines:
Reproducing CE Marking
. The CE conformity marking must consist of the initials 'CE' taking the following form:
If the CE conformity marking is reduced or enlarged the proportions given in the above
graduated drawing must be respected.
Where the directive concerned does not impose specific dimensions, the CE marking
must have a height of at least 5 mm.