The EMC Directive states that equipment shall be designed and manufactured, having regard to the state of the art, to ensure that:
a) the electromagnetic disturbance generated does not exceed the level which radio and telecommunications equipment or other equipment cannot operate as intended;
b) it has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use.
Manufacturers can use the internal production control described in Annex II to comply with the EMC Directive. The manufacturer shall perform an electromagnetic assessment on the product with the view of meeting the protection requirements listed above in points a and b. The manufacturer may want to identify the appropriate European standards from the list of EMC standards, order them, and demonstrate that they comply with the standards. Manufacturers can employ the services of an independent lab to show that a product meets the requirements of the relevant standards. Manufacturers must assemble a technical file which can be available to EU competent authorities. This technical file would include information such as the design of the product, the standards used, and the test certificate obtained from the lab proving conformance to the standards.
The European Commission Guide to the EMC Directive states that the EMC Directive excludes three types of equipment:
- Radio equipment and telecommunications terminal equipment covered by Directive 1999/5/EC (The R&TTE Directive)
- Aeronautical products, parts, and appliances referred to in Regulation 1592/2003;
- Radio equipment used by radio amateurs as defined in International Telecommunication Union (ITU) Radio Regulations.
The Commission’s EMC Guide states that EMC requirements for certain products are covered within that specific product directive. For example, EMC requirements for the Medical Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC), the In Vitro Diagnostic Medical Device Directive (98/79/EC), the Marine Equipment Directive (96/98/EC), the Agricultural and Forestry Tractors Directive (75/322/EEC), the Two or Three-Wheeled Motor Vehicles Directive (97/24/EC), and the Auto EMC Directive (95/54/EC) for parts that affect the safety of a vehicle are covered by requirements in those directives. As a result, products falling under those directives are not covered by the EMC Directive (2004/108/EC). (source www.export.gov)
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