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Overview of the CE Marking Process for the Electromagnetic Compatibility (EMC) Directive This overview of the Electromagnetic Compatibility (EMC) Directive (2004/108/EC) is designed to give U.S. manufacturers an understanding of the main features of the directive and to guide them through the process of certifying for the CE mark requirements. This guide references key websites relating to the EMC Directive, features an updated list of European standards for the EMC Directive, and offers instructions on how to meet CE mark requirements for the directive. The document also provides information on where standards can be purchased and presents a list of labs around the country that can do CE marking. The EMC Directive 2004/108/EC became mandatory for products covered by its scope on July 20, 2009. Please note: The CE mark can only be applied to a product once the manufacturer can declare compliance with all applicable directives. PHASE 1: Does the Electromagnetic Compatibility (EMC) Directive Apply to Your Product? As a manufacturer, you need to secure copies of the directives and judge whether they apply to your product. The purpose of the EMC Directive is to have electronic or electrical products function properly when they are in proximity to other electronic and electrical products by a) ensuring that electrical and electronic products do not emit electromagnetic disturbances that will adversely affect other products; b) making the apparatus immune from incoming electromagnetic disturbances. To view the EMC Directive, go to the European Commission website and click on Directives and Standards. Then, click on the Electromagnetic Compatibility Directive (2004/108/EC). The EMC Directive covers apparatus, components and sub-assemblies, and mobile installations. Apparatus means any finished appliance or combination of appliances made commercially available as a single functional unit which can generate electromagnetic disturbance or whose performance is affected by such disturbance. Components or sub-assemblies are intended for incorporation into an apparatus by the end user. They cannot generate emissions and must be immune from incoming emissions to ensure their intended performance. Mobile installations are defined as a combination of apparatus and where applicable, other devices, intended to be moved and operated in a range of locations. A component made by a supplier for installation into a final product may need CE marking. If the component can be sold commercially and used independently, such as electronic circuit boards, electric motors, or computer disc drives, then CE marking will be required. If the component has no direct function, then it does not need CE marking. Cables and cabling accessories, simple mechanical thermostats, and light-emitting diodes (LED) are examples of components that do not need CE marking. Fixed installations do not have to be CE marked although they do have to meet the requirements of the EMC Directive through sound engineering practices. Fixed installations are defined as a particular combination of several types of apparatus, and where applicable, other devices, which are assembled, installed, and intended to be used permanently at a predefined location. Examples of fixed installations found in the European Commission Guide on the EMC Directive (May 2007) include: Industrial plants, power plants, power supply networks, telecommunication networks, cable TV networks, computer networks, airport luggage handling installations, airport runway lighting installations, automatic warehouses, skating hall ice rink machinery installations, storm surge barrier installations (with the control room etc.), wind turbine stations, car assembly plants, water pumping stations, water treatment plants, railway infrastructures, and air conditioning installations.

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Fixed installations are not assessed by testing to harmonized standards as would be the case for individual pieces of equipment but:
must still meet the essential protection requirements of the EMC Directive; must be installed applying good engineering practice; must have documentation prepared and held by the designated responsible person.

The link below is for the European Commissions Guide to the EMC Directive and to a short guide on the EMC Directive to give further information on EMC issues. (press the control button as you press the mouse to activate the link in the word document). Guide

http://ec.europa.eu/enterprise/electr_equipment/emc/guides/emcguide_may2007.pdf
Quickguide

http://ec.europa.eu/enterprise/electr_equipment/emc/guides/emc_quickguide_en.pdf
PHASE 2: CE Marking Requirements for the Electromagnetic Compatibility (EMC) Directive 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 (see link above) 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 Commissions 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). PHASE 3: Identify the European Standards for the EMC Directive that Apply to Your Product

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While manufacturers are not required to use Harmonized European standards in certifying compliance with the EMC Directive, it is highly recommended as they will find it easier to self-declare or certify that their product meets the legislative requirements by using European standards. Other national, regional, or international standards can be used; however, the use of all applicable Harmonized European standards are preferred since they confer a presumption of conformity to the requirements of the EMC Directive when applied in full. These standards address the essential requirements contained in the EMC Directive. (Note: About 80 percent of the EU standards for the EMC Directive are taken directly from the International Electrotechnical Committee (IEC) standards and just given a European prefix, so U.S. manufacturers are familiar with these standards.) As well as deciding which standards are the most relevant to its product, the manufacturer should consider where its products will be used. Products used in domestic environments generally have to meet more stringent emissions limits, but lower immunity levels than those used in industrial locations. To self-certify, examine the list of standards for the EMC Directive on the European Commissions website at www.newapproach.org (click on Directives and Standards and then on References Harmonized Standards across from the EMC Directive). Pick the standards that apply to your product, looking first for product specific standards which cover the vast majority of products, and if there arent any, then choose the generic EMC standards for emissions and immunity. EN 61000 6-4:2007 is the generic standard for emissions for industrial environments. EN 61000 6-2:2005 is the generic standard for immunity for industrial environments. There are also generic emissions and immunity standards for residential, commercial and light-industrial environments. The manufacturer should also examine the EMC standards on harmonics (EN 61000 3-2) and voltage fluctuation (EN 61000 3-3) for their possible applicability. Those standards affect many product areas, particularly information technology. The manufacturer would then order the standards he or she has decided are appropriate for the product. The Consultants/Ordering Standards line on the sidebar of this webpage lists sources for ordering standards. European standards are only available from an approved distributor and must be purchased. PHASE 4: Conform to the Appropriate Standards and Set Up a Quality System Once the company has ordered and received the appropriate European standards, its engineering or technical department can start applying the standards to the design and production phase of its product. The standards contain all the detailed information, diagrams, and tests that are necessary to meet the requirements of the EMC Directive. The directive is general in scope, saying that a product must not release emissions that could interfere with nearby electrical equipment and must also be immune from incoming emissions so that the product will function in its intended fashion. Typically, there should be at least two standards for the EMC Directive one covering emissions and one for immunity. The details and specifics to meet the requirements of the directive are found in the European standards. A company will also need to set up a quality system to ensure that products manufactured in the future will meet CE mark requirements. This is important as the manufacturer is declaring that all products manufactured comply with the relevant directives and a suitable quality system can track in-life product changes and ensure that changes are not introduced without their effect on CE marking being properly considered, reviewed and documented. A company is not required to use a certain type of quality system. If a manufacturer does not use Harmonized European standards, or does not apply them in full, it will have to show the solutions it used to meet the requirements of the EMC Directive in its technical file. PHASE 5: Get a Lab Test to Prove Conformance to the EMC Standards Once a company has chosen the relevant standards for the EMC Directive, it will need a lab test to prove that the standards were met. For a list of labs that can do testing and certification for the EMC Directive, see the link Testing/Certifying Labs on the sidebar on this page. This list is not an endorsement for any laboratory. There are other labs, not listed on the link, that can do testing for the EMC Directive. In addition, the National Institute of Standards and Technology (NIST) has a list of labs on their website that has been designated as Conformity Assessment Bodies (CABs) under the mutual recognition agreement with the European Union. These labs can also do testing for CE marking requirements for the EMC Directive. (After accessing the website, click on U.S. Cabs for EMC and R&TTE beginning January 16, 2001.) The manufacturer can go to an EU-affiliate lab or an independent lab. If a company has the equipment to test to European standards, it can do its own testing in-house.

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A company can self-certify for the requirements of the EMC Directive by either using European standards or by using non-European standards. However, it is easier to demonstrate compliance with the EMC Directive by using European standards. The EMC Directive indicates that a product must meet emissions and immunity requirements but it does not say what the limits or values of those requirements are. The directive leaves that question up to the European standards. The European standards give the specific values for emissions and immunity for certain products which the directive does not give. Companies can use non-European standards, but the question about whether those standards provide the emissions and immunity values needed to comply with the EMC Directive is harder to gauge. European standards for EMC are geared specifically to meet the requirements of the EMC Directive. As mentioned earlier, about 80 percent of the European standards for the EMC Directive are derived from IEC standards and given European (EN) prefixes. U.S. companies are familiar with IEC standards. After a product has passed the testing, the manufacturer needs to obtain a certificate from the lab showing the product has met European standards for the EMC Directive. If the manufacturer did not use European standards, then the manufacturer must show that the solutions he has drawn up will meet the requirements of the EMC Directive. The onus is on the manufacturer to demonstrate that he meets the EMC Directive. The manufacturer may use guidance from test labs or other third parties, but it is the manufacturer who needs to explain how the standards chosen demonstrate compliance. The manufacturer does have the option of getting the product tested, approved, and certified at an EU notified body. PHASE 6: Assemble a Technical File The technical file must prove that the company has met the CE mark requirements for the EMC Directive. It must cover the design and manufacture of the apparatus by giving the following information:
a general description of the apparatus; evidence of compliance with the harmonized standards, if any, applied in full or in part; where the manufacturer has not applied harmonized (European) 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.
PHASE 7: Affix the CE Marking to Your Product A picture of the CE mark is shown in Annex V of the Electromagnetic Compatibility Directive (2004/108/EC). The CE marking must have a height of at least 5 mm. If the CE marking is reduced or enlarged, the proportions of the CE mark must be respected. The CE marking must be affixed to the apparatus or to its data plate. Where this is not possible or not warranted because of the nature of the apparatus, it must be affixed to the packaging, if any, and to accompanying documents. Once the manufacturer has met the requirements for all the CE marking directives that apply to his product, then the manufacturer makes up the CE marking and attaches it to each product. The manufacturer does not obtain the CE mark from a government agency in either the EU or US. If a product is covered by more than one CE marking directive (such as by the Machine, Electromagnetic Compatibility, and Low Voltage Directives), then it is assumed that the CE marking will not be put on the product until CE marking requirements have been met for all of the directives the manufacturers product falls under. PHASE 8: Create a Declaration of Conformity The declaration of conformity is the document showing that the manufacturer has met CE marking requirements for the product being placed on the EU market. The declaration of conformity can accompany each shipment to show EU customs authorities that the imported product meets CE marking requirements. The declaration of conformity then goes to the customer who keeps it on file in case EU authorities have questions about the compliance and origin of the product. A U.S. company official from the manufacturer must sign the declaration of conformity to indicate that the firm is backing its claim of meeting CE marking

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requirements. The EMC Directive (2004/108/EC) states that the company filling out the declaration of conformity must list the standards it used to meet the requirements of the EMC Directive. Please note that Annex II of the EMC Directive, point 7, states that if neither the manufacturer nor the authorized representative is established within the European Community, then the obligation to hold the EC declaration of conformity and the technical documentation at the disposal of the competent authorities shall lie with the person who places the apparatus on the Community market. In other words, the company putting the product in service has to have quick access to the manufacturers technical file, whether by fedex or email, in the event EU competent authorities ask for the technical file. For a sample declaration of conformity, please see the Declaration of Conformity Example link on the sidebar of this page. There is no mandatory format for the declaration of conformity, however general guidance is given in Draft Certif 2005 2 from the European Commission referencing EN 45014:1989 General criteria for suppliers declaration of conformity:

http://ec.europa.eu/enterprise/newapproach/pdf/sogs_n506_draft_certif_2005_2_version2.pdf
A declaration of conformity must include:

a reference to this Directive, an identification of the apparatus such as type, batch, and serial number, the name and address of the manufacturer and, where applicable, the name and address of his authorized representative in the Community, a dated reference to the specifications (ie, standards) under which conformity is declared to ensure conformity of the apparatus with the provisions of this Directive, the date of that declaration, the identity and signature of the person empowered to bind the manufacturer or his authorized representative

PHASE 9: Keep Posted on Updates of Standards Which Might Affect Your Product The European Union reviews its directives regularly and issues new EMC standards periodically. U.S. companies complying with the CE marking for the EMC Directive should check the European Commissions website once every 4-6 months to see if new standards have been issued that might affect their product. These new standards usually have a lead time of a couple of years, giving companies time to conform to the new requirements, which usually include additional tests, performance monitoring criteria or extending test frequency ranges beyond those in the standards they replaced. Once the new standard is published in the Official Journal, it is usually accompanied by a Date of cessation of presumption of conformity of the superceded standard (DOCOPOCOSS) after which, the old standard no longer gives presumption of meeting CE mark requirements. A company that has not stayed current and fails to adopt a new standard is technically violating CE mark requirements and could be prosecuted by EU authorities. More Information is Available: If you need more information on getting the CE marking for the EMC Directive, call the U.S. Department of Commerce EU specialists: Bob Straetz at 202-482-4496 in the Office of EU Affairs or Sylvia Mohr at 011 32 2 508 2675 at the U.S. Mission to the EU in Brussels, Belgium. Consult the U.S. Commercial Service website at http://www.buyusa.gov/europeanunion Duquesne University Center for the International Regulatory Assistance, partially funded by the U.S. Small Business Administration and the Market Development Cooperator Program of the U.S. Department of Commerce, has information on the CE marking at http://www.citra.duq.edu

http://export.gov/cemark/eg_main_017281.asp

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