Products containing circuitry (components) under the EMC Directive 2004/108/EC requirements, it is required to carry out tests for electromagnetic compatibility (EMC) with the CE mark law, which gives the opportunity to import the output to all European Union countries. For the purpose of the EMC test, it is sufficient to present one output sample, but if it is difficult, experts will conduct an on-site inspection, followed by the conclusion of an article under the EMC Directive and the harmonized standards with the certificate of compliance issued.
Products relating to the EMC Directive, compliance can be evaluated by two CE certification schemes. According to the evaluation procedure - internal production control, if the manufacturer is in the European Union's territory then an electromagnetic compatibility assessment of the product can be done for safe performance objective. The manufacturer has a responsibility to correctly apply the harmonized standards relating to EMC Directive.
The manufacturer must prepare the technical documentation (technical file), which must include:
- a general description of the product;
- the project documentation;
- information on compliance with the harmonized standards applied in full or in part;
- if its manufacture was partly applied harmonized standards or technical regulations were applied, the manufacturer is obliged to describe the steps that must not be contrary to the Directive 2004/108/EC, this description should be included in the project estimate, test protocols and results of tests performed.
The technical documentation must be kept by the manufacturer (an EU authorized person) for ten years from the last product release moment. If the manufacturer is located within the European Union, he issues an EU Declaration of Conformity, whereas if the manufacturer is located outside the EU, the declaration of conformity is entitled to issue a manufacturer's authorized representative in the EU. The technical documentation and the EU declaration of conformity is immediately presented to the EU controlling authorities at their request.
EC declaration of conformity must contain the following information:
- references to 2004/108/EC Directive;
- product identification;
- manufacturer or EU authorized person's name and address;
- standards;
- the release date of the EU Declaration of Conformity;
- identification of the person who signed the EU declaration of conformity.
Second conformity assessment procedure is carried out in accordance with an EMC directive authorized body, issuing a certificate of conformity. Regardless of the certification procedure was applied to relevant product in case of compliance, products must be labeled with the CE Mark.
The time in which the work is performed usually takes no more than two weeks after the conclusion of the contract and the laboratory sample reception.
Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC Directive EMC
