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The most common hurdle for manufacturers in dealing with the European CE marking system is mastering the compliance requirements of the Electromagnetic Compatibility Directive 89/336/EEC. In dealing with EMC compliance, companies need to mitigate three cost-drivers: EMC testing, increased marginal cost per component due to CE certification, and the involvement of a Competent Body. Most companies leverage one of three compliance alternatives to achieve EMC conformity:
  • Article 10(1) - testing to harmonized standards;
  • Article 10(2) - Technical Construction File (TCF) without testing;
  • Article 10(2) - TCF with testing.

    A perfect example of leveraging the opportunities and compliance alternatives within the EMC directive is ABC Company, a manufacturer of control panels. The company was faced with the problem that their product line consisted of approximately 20 control panels. The models are pretty similar in their layout, but different enough to cause a confrontation with the requirements in the EMC directive. After ruling out the compliance route as outlined in Article 10(1) for economic reasons, SIMCOM was able to provide ABC Company with the option to pursue Article 10(2) without testing.

    Note: It is important to note that Article 10(2) always requires the intervention of a Competent Body to issue a Certificate of Conformity after the review of the TCF. The certificate remains in the company technical file and serves as the documented evidence that the selected apparatus fulfills EMC requirements. The Competent Body is hereafter cited on the Manufacturer's Declaration of Conformity.

    The primary task function is based on the careful creation of an engineering rationale describing all areas of potential EMI/EMC sources and outlining how those risk sources have been eliminated or reduced to an acceptable level. In case of ABC Company, the collection of Declarations of Conformity from parts suppliers was a significant step into the right direction. The Competent Body received all necessary paperwork to approve the TCF and issue ABC Company a Declaration of Conformity. At the end, ABC Company saved thousands of $$$ in redundant EMC test costs and was still able to prove conformity to the European EMC directive.

    Please contact a SIMCOM International account representative at 888-501-1315 or via e-mail at service@esimcom.com to see if the TCF route can help you saving money when proving conformity to the EMC directive.



  • Click here to browse for standards associated with each specific European Union New Approach Directive.

    Keywords: CE marking, CE Mark, European business, EU regulations, EU business requirements, European trade barriers, New Approach directive, technical construction file, EN, prEN, ISO, IEC, ITU, ETSI, CEN, CENELEC, EU regulatory compliance