The European Union Directive on EMC
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The European Union Directive on EMC |
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This document has been prepared by Ganymede Test & Measurement to provide basic guidance to manufacturers and importers of electrical apparatus encountering the European Union Directive on EMC for the first time. It summarises the principle requirements of the directive and outlines how compliance can generally be achieved.
The document is presented in the form of questions and answers.
Please feel free to make copies of this page so long as you maintain a reference to Ganymede Test & Measurement.
The directive is essentially a liberalising measure designed to prevent national governments misusing national standards in order to erect artificial trade barriers. It provides a common framework for ensuring that equipment neither causes nor is subject to radio interference in its normal operating environment.
The directive defines the following four classes of product:
Of these, Apparatus and Systems are subject to the directive, whilst Components and Installations are exempt. Note that the basis of the exemptions is that components will be incorporated into equipment which will itself be subject to the directive; and similarly, that installations are comprised of equipment subject to the directive.
It indicates that your equipment is compliant with all applicable EU directives. Note that it may not be sufficient to only meet the EMC directive.
Yes. Depending on the class of equipment, a number of other EU directives may be applicable; for example the Telecommunications Terminal Equipment (TTE) directive covers equipment connected to public telephone networks; the Low Voltage directive covers (mainly) the safety of mains powered equipment. Other directives cover toys, medical devices, etc.
Some types of equipment (eg Cable TV apparatus) will be installed into networks which will be subject to additional EMC requirements over and above those of the EU directive. Compliance with the directive does not guarantee that you will have a market for your products.
If harmonised standards have been advised for your product and if your product fully meets the standard(s), then you are permitted to make a self-declaration that your product is compliant. This will normally be the least costly route to compliance.
This is not laid down. You (or your agent) must satisfy yourself that the product meets the standard and you must maintain for a period of ten years documentary evidence of the basis of the certification.
If your product does not meet a harmonised standard, or if a harmonised standard does not yet exist for your product, it is still possible to obtain certification. However, in this case, your evidence must be independently assessed by a 'Competent Body'. This is known as the "Technical Construction File" route to certification. The technical construction file route is also applicable if you manufacture a large number of broadly similar products which it would be impractical to assess individually.
The Competent Bodies are independent organisations which have been authorised by the Department of Trade & Industry to make technical assessments of products and to pronounce whether they meet the conditions of the directive.
This contains the body of technical evidence which you submit to a Competent Body in order to obtain certification. It can be prepared by yourself, by your agent, or by the Competent Body making the assessment.
These are the standards which are being prepared under the auspices of CENELEC and ETSI which will supersede the national standards in all the member states of the EU.
It is not permissible to self-certify to draft standards. If standards for your equipment are still in draft, then you must either self-certify to appropriate generic standards, or alternatively, you may apply the draft standard under the Technical Construction File procedure.
Failures in service are not covered by the directive. However, if you become aware that your equipment has failed due to a design defect, then you would be obliged to reconsider the validity of any certificate you had issued.
No, although in some circumstances this will be the most cost effective means of ensuring conformity.
Assuming, the standards can be shown to be equivalent, or an equivalence can be extrapolated, then there would be no need to re-test.
The principle penalty is that your product will be removed from the market throughout the European Union. In addition you are liable to fines and imprisonment if it can be shown that you have wilfully made a false declaration.
If you can show that you have seriously attempted to comply with the directive and that you non-compliance is due to a genuine oversight, then you will be deemed to have 'exercised due diligence' and will probably not be liable to prosecution. However, your product will still be removed from the market.
It is not expected that there will be any proactive random checking of certificates. The enforcement authorities are the local Trading Standards Departments who have said they will react to complaints from customers and peers of suspect equipment manufacturers. At least one manufacturer has declared an intention to 'out' those of his competitors whom he knows or believes to be in breach of the directive's requirements.
The DTI is a useful source of information and guidance. The British Standards Institute runs a 'Technical Help for Exporters' Desk which gives advise on the directive to members. The UK regulations implementing the directive are published by HMSO.
Further specific advice is available from Ganymede Test & Measurement.
Companies wishing to maintain a legitimate presence in the market place should nominate a responsible person who will be accountable for ensuring compliance under the directive. and who will put in place a strategy for completing the formalities within the required timescales.
In many cases, it will be advisable to carry out a relatively low cost initial assessment of the relevant product(s) in order to quickly identify possible problem areas and to decide whether self-certification is appropriate for the product(s). At this stage it will usually be clear what further steps (if any) will be necessary to ensure compliance and to make the appropriate declarations.
In the current rather fluid standards situation, with many proposed harmonised standards still under discussion,. it is essential to review your EMC strategy at regular intervals and to keep abreast of the changing requirements.
Ganymede Test & Measurement
8 Hillman Close
Uxbridge
UB8 1QA
Tel/Fax =+44 (0)1895 251897
April 1997
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