Requirements of the Directive
• Performance of equipment with regard to all forms of radio interference.
• Basic ‘essential protection’ requirement – not to interfere with other apparatus, not to be interfered with by other apparatus.
• Perform EMC testing / assessment
• Compile a Technical File
• Prepare a Declaration of Conformity
• Put CE Mark on the product
The Directive applies to:
• Any “relevant apparatus”; basically, if EMC performance can be meaningfully measured, then the directive applies.
• Installations (i.e. an assembly of individual pieces of apparatus brought together on a specific site).
There are some exclusions listed in the Directive:
• Equipment built or assembled by radio amateurs
• Equipment intended for use in commercial aircraft
• Equipment covered by directives containing more specific EMC provisions (e.g. automobiles (2004/108/EC)
• Weighing equipment (2004/22/EC)
• Telecommunication apparatus (1999/5/EC)
• Directive does not recognise lower or upper frequency limits (“d.c. to light”) but in practice standards mainly provide for tests covering a range from 10kHz to 30GHz.
Please refer to the EMC directive for detailed requirements.
Services that we offer as a Notified Body
• Technical File Review:
A Technical File is required in order to comply with the EMC Directive. We will review your Technical File for conformity to the requirements of the directive and provide recommendations on any areas requiring further action or improvements.
• Technical File Lodging:
CTI-CEM will acknowledge receipt and provide secure storage for 10 years after the date of last manufacture.
• EMC Testing Service:
If required, CEM will arrange for equipment to be tested to ensure that it conforms to the requirements of the EMC Directive.
Annex II to the EMC Directive requires the manufacturer to establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The technical documentation should comprise:
• A general description of the apparatus;
• Evidence of compliance with the harmonised standards, if any, applied in full or in part;
• Where the manufacturer has not applied harmonised standards, or has applied them only in part, a description and explanation of the steps taken to meet the essential requirements of the Directive, including a description of the electromagnetic compatibility assessment set out in Annex II, point 1, results of design calculations made, examinations carried out, test reports, etc;
• A statement from the notified body, when the procedure referred to in Annex III has been followed.
The manufacturer or his authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed on the market.
How we can help
CTI-CEM International are a notified body for the Machinery Directive and can provide assistance with certification.