FAQ's about the EMC Directive

I have been selling my product for years, and no one has ever complained about it interfering. Why is the European Union (EU) requiring all this testing and compliance documentation for EMC? Isn't it really a trade barrier?
The EMC Directive and other CE Marking Directives apply to all manufacturers of products affected by the individual directives. This includes manufacturers within the EU. The New Approach Directives came about as a means to reduce barriers to trade. Prior to these New Directives, each country in the EU imposed obligations on business in the interests of safety, consumer protection, etc. They, in turn, were barriers to trade because of the different requirements in different countries. The New Approach Directives provides a common harmonized approach to the essential requirements of each country.

Do I have to use a test house in the EU? Can I do the testing myself?
You can test anywhere you wish as long as the equipment, capability and expertise exist to produce test results according to the requirements of the International Harmonized Standards produced by CEN and CENELEC, identified by the designation EN. Technology International has established a network of Test Laboratories which have all been assessed under the guidelines of ISO Guide 25, the international standard for test facilities, and can ensure competent testing.

What exactly is CE Marking, what products require it, and where do I get it?
The CE Marking is a certification marking of products sold within the EU. This one mark supersedes all individual national marks of countries in the EU and symbolizes that a product has met all applicable New Approach Directives. The New Approach Directives are product and/or industry specific and address issues such as Electromagnetic Compatibility (EMC), Product Safety, Medical Devices and several others.

The manufacturer is responsible for affixing the CE Marking to his product after meeting the requirements of the applicable Directives. It may not be smaller than 5mm in its vertical height and have the correct proportions described in the CE Marking Directive, 93/68/EEC.

Whats the difference between a Competent Body and a Notified Body?
Most New Approach Directives appoint bodies for regulatory approval purposes. These bodies are appointed according to the requirements listed in the individual directives. These regulatory bodies are then notified to Brussels, Belgium for publication in the Official Journal of the European Communities. Only the EMC Directive provides for the appointment of Competent Bodies because the regulatory duties required under the EMC Directive are viewed to be highly dependent upon the technical expertise of these organizations. Under the UK Regulations, each Competent Body must prove their competence in the field of Electromagnetic Compatibility by demonstrating depth and breadth of personnel experienced in the field of EMC, evidence of experience through project histories, and a sufficient level of professional liability insurance prior to appointment by the government.

What requirements must be met to comply with the EMC Directive?
The requirements of the EMC Directive state that the product must not generate a level of disturbance which prevents radio and telecommunications and other apparatus from operating as intended and must have a level of immunity to enable it to operate as intended. There are two routes available to demonstrate that these requirements are met. They are:

Standards Route (Self Certification) - Compliance route available for apparatus involves self-certification by the manufacturer against the appropriate requirements of the Harmonized Standards.

Technical Construction File (TCF) - Compliance route also available for apparatus, where there are no European Harmonized Standards or where the manufacturer chooses not to apply such standards.
The TCF allows for flexibility in regulatory changes, lowers certification costs by reducing time to market, paperwork, and testing requirements in many cases, and provides compliance procedures with longevity.

Why would I want a Technical Construction File? Can't I just follow the standards route for my products and wouldn't it be cheaper?
You may choose whichever route is appropriate to your product but it may not necessarily be the least expensive alternative. In general, the TCF route to compliance is both cost-effective and provides a long-term compliance solution if you manufacture a product(s) that does not meet any acceptable standards, if your product(s) is sold in several variations, if testing is impractical, or if you foresee changes to your product in the future. In these instances, a TCF is effective for compliance because it is valid for the life of your product. The standards route is more applicable in instances where you are certain that your product meets a specific European standard, the standard is not likely to change, or if you do not foresee any changes to your product in the future. This route can be more costly in instances where either the standard or the product is modified, requiring you to perform additional testing to remain compliant.

What products require a Technical Construction File (TCF)?
The answer to this question is not as much which products require a TCF, rather which products will benefit from the development of a TCF. In general, if the product/system exists in more than one variation, is likely to be modified in the future, or is not practical to test because of size or other constraints, a TCF should be considered. Also, if it is difficult to identify applicable Harmonized Standards or if the applicable standards are likely to be modified in the future, then a TCF should be created.

How do I determine what standard(s) I apply to my product and put on my Declaration of Conformity (DoC)?
When working with Technology International, our consultants would need to examine information about the product or product line, or at least discuss the product in detail to determine what standards we would apply.

If you are using the Standards Route to compliance - you may only declare compliance with those standards that are both ENs and have been published in the Official Journal of the European Communities as being available for use with the EMC Directive. This presumes that the manufacturer has strictly adhered to all of the requirements of the standard. The list is incremental and new standards are added periodically as they become accepted by the European Commission.

When using the Technical Construction File (TCF) Route, the TCF itself should be mentioned along with any ENs referenced by the TCF. A Competent Body must legally review the technical construction file and issue a report and/or certificate saying the product or system meets the essential requirements of the EMC Directive. It is therefore not necessary to worry about standards changing and being updated for this product or system, because the Directive states that a TCF legally assessed by a Competent Body is valid for the indefinite life of the product.


Do the components we manufacture need CE Marking?
Be careful. Different directives define components differently. Under the EMC Directive, however, a component is a product intended for use as part of a large product or system which is not supplied directly to an end user as a single commercial unit. Products so supplied are still considered components if they have no intrinsic function.

How can Technology International help me with the EMC Directive?

Technology International can be instrumental in the following areas: