Overview of the CE Marking Process for the Electromagnetic Compatibility (EMC) Directive

This overview references key websites relating to the EMC Directive, an updated list of standards for the EMC Directive, and instructions on how to certify for the EMC Directive. This document also provides information on where standards can be purchased, and presents a list of labs around the country that can do CE marking testing for the EMC Directive.

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 European Commission does not publish a list of products to which their laws apply; they require the manufacturer to determine the applicability of directives to any given 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. Annex III of the EMC Directive lists types of products that are covered by the directive. To view the EMC Directive, go to the European Commission's website at http://www.newapproach.org and click on “Directives and Standards.” Then click on the Electromagnetic Compatibility Directive.

In the case of the EMC Directive, a component made by a supplier for installation into a final product may need CE marking. The general rule is that if the component can be sold commercially and used independently, such as electronic circuit boards, electric motors, or computer disk drives, then it needs CE marking. 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. The National Institute of Standards and Technology (NIST) publication, “A Guide to the EU Directive on Electromagnetic Compatibility” at http://ts.nist.gov/europe explains which components need CE marking and which do not.

Please note that the existing EMC Directive will be repealed as of 20 July 2007 to be replaced by the new Directive 2004/108/EC of the European Parliament and of the Council, of 15 December 2004, on the approximation of the Laws of Member States relating to electromagnetic compatibility, published in the OJEU on 31 December 2004 (L 390/24).

PHASE 2: CE Marking Requirements for the Electromagnetic Compatibility (EMC) Directive

The Electromagnetic Compatibility (EMC) Directive sets out the essential requirements for electromagnetic emissions and immunity and covers all equipment likely to cause or be affected by electromagnetic disturbance. Radio communications equipment must be certified by a third party (EU notified body) to signify compliance for EMC requirements under the Radio and Telecommunications Terminal (1999/5/EC) Directive. For all other types of equipment, manufacturers can self-certify by choosing the European standards appropriate to their product, conforming to the standards, and then getting a test result to prove conformance with the European standards. As long as the U.S. company has used European standards, it can get the test result from any lab that has the equipment to show that the standard was met, including an in-house lab.

For manufacturers who desire, or whose products require, third party testing, such testing is carried out by “notified bodies” or their affiliates. Notified bodies are companies which have been selected by the EU member states and “notified” to the European Commission as being competent to test and certify products under a particular directive where third party testing is required. Notified bodies must be located in the EU and are the only entities allowed to give final product approval under the directives requiring the CE arking, although their affiliates outside the EU are allowed to test products and send results to the parent for approval.

The U.S. government has negotiated agreements in several sectors, including EMC, which allow laboratories located in the U.S. to test and certify products to EU requirements, and vice-versa. These “mutual recognition agreements” (MRAs) will cut costs and save time for manufacturers on both sides of the Atlantic. For more information on the MRAs, please see http://ts.nist.gov/mra. See the Testing/Certifying Labs link on the sidebar of this page and throughout this website for a list of labs.

For more information on the CE mark and the EMC Directive, including how to certify for the EMC Directive, please consult the guides published by the National Institute of Standards and Technology (NIST) entitled: 1) “NIST SP 951 – A Guide to EU Standards and Conformity Assessment” and 2) “NIST GCR 813 – A Guide to the EU Directive on Electromagnetic Compatibility” at http://ts.nist.gov/europe.

PHASE 3: Identify the European Standards for the EMC Directive That Apply to Your Product

While manufacturers are not required to refer to European standards in certifying compliance with the EMC Directive, they will find it easier to self-declare or certify that their product meets the legislative requirements by using European standards. While other national, regional, or international standards can be used, European standards are preferred since they are presumed to address the “essential requirements” contained in the EMC Directive.

To self-certify, examine the list of standards for the EMC Directive on the European Commission's website at http://www.newapproach.org (click on “Directives and Standards” and then on "Harmonized standards for the Electromagnetic Compatibility Directive"). Pick the standards that apply to your product, looking first for product specific standards and if there aren't any, then choose the generic EMC standards for emissions and immunity. Also, examine the EN 61000 series of EMC standards on harmonics for their possible applicability. Those standards affect many product areas, including information technology. Then, order the standards you’ve decided are appropriate for your product. The Consultants/Ordering Standards link on the sidebar of this page and throughout this website lists some sources for ordering standards.

PHASE 4: Conform to the Appropriate Standards

Once the company has 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 correctly. So, 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.

PHASE 5: Get a Lab Test to Prove Conformance to the EMC Standards

Once a company has applied the standards for the EMC Directive, it will need a lab result 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 and throughout this website. This list is not an endorsement for any laboratory. There are other labs, not listed on our 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 at http://ts.nist.gov/mra that have 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.)

If a company has used European standards, it can self-certify. The firm must indicate to the lab that the company only needs a test result verifying the European standards it used. The lab would charge more for assessing the product, figuring out what standards to use, applying the standards, and testing than it will for just producing a test result. As long as a company used European standards, it can get a test result from any lab that has the equipment to test to the standard. The manufacturer can go to an EU-affiliate lab or an independent lab. In fact, if a company has the equipment to test to European standards, it can do the testing in-house.

After a product has successfully passed the tests, the manufacturer needs to obtain a certificate from the lab showing the product has met European standards for the EMC Directive. This certificate forms the core of the company’s technical file (see PHASE 6) showing that the product met CE marking requirements for the EMC Directive.

If a manufacturer chooses not to use European standards, then it cannot self-certify. It will have to take its product to a lab where they will do testing and certification for compliance with the EMC Directive. This will result in a price that is usually quite a bit higher than if the company had applied European standards and used a lab (either EU-affiliate, independent, or in-house) just to provide a test result. When choosing a lab to test and certify a product on which non-European standards were applied, make sure the lab is connected to a notified body, since a notified body is the only organization that can issue a certificate for CE marking. An EU-affiliate lab that is connected to a notified body is called a “competent body” lab. You could also take your product to one of the Conformity Assessment Bodies (CABs) listed on the NIST website http://ts.nist.gov/mra to receive testing and certification if you did not use European standards.

PHASE 6: Assemble a Technical File

If the manufacturer self-certifies by using EMC harmonized standards in the design, production, and testing of the product, it needs only to affix the CE marking and draw up a written declaration of conformity. Although no technical file is required, it is recommended that manufacturers retain all relevant technical documentation as if it were a technical file.

The technical file is the evidence a manufacturer collects while certifying for the directive. The technical file contains records, tests, diagrams, and a list of standards which the manufacturer used in order to meet CE marking requirements. The technical file is designed to help the manufacturer keep track of the procedures and steps it took to get the CE marking and must also be available to European authorities in case they have questions on whether a product meets CE marking requirements.

If the manufacturer has not used EMC harmonized standards or only parts of them, it must compile and keep a technical file.

The technical file should contain the following:

A general description of the product;

Design and manufacturing drawings, together with layout diagrams covering components, subassemblies, circuits, etc.;

Descriptions and explanations needed in order to understand the abovementioned drawings and diagrams as well as the operational aspects of the product;

A list of standards applied in whole or in part and a description of the solutions adopted in order to comply with the protection requirements of the EMC directive in cases where the standards have not been applied;

Design calculation results arising from the EMC tests;

The technical report or the certificate issued by a competent body (EU-affiliate lab connected to a notified body–see paragraph below);

A copy of the declaration of conformity (discussed in the next section);

A copy of the instructions for use (see Annex III of the directive).

A manufacturer must also obtain a report or certificate from a competent body showing that the conformity assessment procedures for the parts that were not covered by harmonized standards have been correctly performed, regardless of whether they were done by the manufacturer or the competent body.

The technical file and report or certification from a competent body must be made available for inspection by EU surveillance authorities for 10 years after the last product was placed on the market.

PHASE 7: Affix the CE Marking to Your Product

The European Commission's, "Guide to the Implementation of Directives Based on New Approach and Global Approach" contains a picture of the CE marking and a brief description of it. Click on 7, CE Marking and go to page 45 to see the picture of the CE marking. The CE marking must be indelibly affixed to a product. It does not have to be branded onto a product but it must be affixed so that it will not come off. The two letters (CE) must have the same vertical dimension, which may not be less than 5 millimeters in height. Once the manufacturer has met the requirements for the CE marking directives that apply to its product, then the manufacturer makes up the CE marking and attaches it to each product. 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 the directives the manufacturer’s product falls under.

PHASE 8: Create the Declaration of Conformity

The declaration of conformity is the document showing that the manufacturer, or his authorized representative, has met CE marking requirements for the product being placed on the EU market, in this case the EMC Directive. The declaration of conformity must 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. The declaration of conformity must be signed by either a U.S. company official from the manufacturer, or by an authorized representative, to indicate that the firm has taken responsibility for its claim of meeting CE marking requirements.

For a sample declaration of conformity, please see the Declaration of Conformity Example link on the sidebar on this page and throughout this website. There is no standard format for the declaration of conformity. However, the declaration of conformity must include the following pieces of information:

Name and address of the manufacturer or his authorized representative;

Description of the product (including model and serial number);

All relevant CE marking directives the product complies with;

Reference to the harmonized standards used, if appropriate;

Location where technical file is being kept;

Identification of the person empowered to sign on behalf of the manufacturer or his authorized representative. (And that person’s signature, indicating the company has taken responsibility for its claim of meeting CE marking requirements for the directives listed on the declaration of conformity.)

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 Commission's website at www.newapproach.org 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 are usually stricter than the standards they replaced. Once the new standard is implemented, the old standard no longer gives presumption of meeting CE marking requirements. A company that has not stayed current and fails to comply with a new standard is technically in violation of the CE marking requirements and could be prosecuted by EU authorities.

More Information is Available:

If you need more information on getting the CE marking for the Low Voltage Directive, call the 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 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.