The Reality and Myths of The EMC Directive

As the transition period for the EMC Directive comes to an end, chaos has hit the EMC community in the United States. Manufacturers are clamoring to meet the Jan. 1 deadline while independent laboratories are struggling with schedules and capabilities to meet the demand for testing. Even with this tremendous amount of activity–activity which has gone on for several years–both manufacturers and laboratories are confused about the interpretation and implementation of the EMC Directive.

In defense of us Americans, there are several issues at play which have put us at a disadvantage. The lack of input to both the standards writing and regulatory writing does not help. And the non-unification of the alleged unified European Union (EU) is also an issue.

Finally, U.S. manufacturers are having a difficult time understanding and working with a manufacturer-friendly system, specifically one based, in many areas, on a manufacturer’s Declarations of Conformity. This is almost a classic case of “Be careful what you wish for because you may get it.”

To clear up many misunderstandings, let’s look at the basics of the European system in general, and the EMC Directive specifically.


The EU’s system for all Conformity Assessment (product-approval) procedures is based on the document The Global Approach to Testing and Certification released in 1989. In this document, the EU defined various routes, or modules, to compliance.

Figure 1 shows the individual modules. The more complicated or hazardous the product type, the more complicated the approval process.

Even when the procedures become more complicated, the EU system allows the manufacturer to make choices. For example, in Figure 1, Module B can be combined with either Module C, D, E or F.

The EMC Directive

The EMC Directive is generic, covering a range of products crossing over many product disciplines. As with all directives, the heart of the EMC Directive is its Essential Requirements (Figure 2). When a manufacturer attests that a product meets the requirements of the EMC Directive, that means the product meets these essential or basic requirements.

A manufacturer has several routes to compliance within the EMC Directive; however, these routes (Articles 10.1, 10.2 and 10.5) are basically defined by the type of product involved. Figure 3 shows the routes to compliance and the basis for each.

The most common route is a manufacturer’s self-certification through a Declaration of Conformity as defined in Article 10.1. This route is available when a product can show compliance with the essential requirements through application of the harmonized standards. A standard is harmonized when all members of the EU agree to the requirements in a standard.

Harmonized standards are EN standards, such as EN 55011 and EN 55022. If you can show compliance with the requirements of such standards, you can self-certify your product.

The second route is a bit more complicated and requires the use of an EU-designated Competent Body. This route, defined in Article 10.2, must be used when either no harmonized standards have been developed or when the harmonized standard cannot be applied.

EN standards are being developed daily; however, it is possible that not all products currently covered by the EMC Directive have harmonized standards. When this occurs, a Competent Body must be used. The Competent Body will develop a customized test plan for the product to show compliance with the essential requirements of the Directive.

This is also the case when, even though a harmonized standard exists, it cannot be applied to the product. A good example is a very large supercomputer which cannot be tested in a laboratory setting. It is Information for Technology Equipment, but harmonized standards such as EN 55022 cannot be applied to the letter of the law.

Here, too, a Competent Body must prepare a customized test approach. Once the test plan has been developed, engineering studies and testing can be performed, followed by a test report. The Competent Body must approve the test report and generate a Technical Construction File. Once this process has taken place, the manufacturer can prepare a Declaration of Conformity and CE mark the product.

The final route within the EMC Directive is defined in Article 10.5. This route is specific to RF transmitters and is the least used of the three. It requires testing and approval of the product by EU-designated Notified Bodies. Transmitter approval presents a major problem because of the non-unification of the EU.

Before we look at some of the myths related to the EMC Directive, let’s clear up one source of continued confusion: the difference between a Technical File and a Technical Construction File. Many people interchange these terms when, in fact, they have quite different purposes.

A Technical File can be generated by anyone to support a manufacturer’s Declaration of Conformity. A Technical Construction File can only be generated by an EU-designated Competent Body when compliance is shown through Article 10.2.

The Myths

Many, if not all, of the myths associated with the EMC Directive are a direct result of Myth #1.

Myth #1–Product approval in the EU is controlled by a unified system.

When you understand the EU conformity assessment system, it is simple to understand why confusion exists about product approval. The system is not as well-unified as you might think.

Directives are basically guidelines and they mandate that member states enact laws to, in turn, enact the spirit of the Directive. As a result, we have a situation where each member state is generating its own law, which is its interpretation on how to best enforce the Directive.

Member states also are appointing their own competent authorities who, in turn, appoint the member state’s Competent and Notified Bodies. Guess what? They all do not designate these bodies the same, resulting in a system where not everyone interprets everything the same. Let’s face it. There is no strong central authority, such as our FCC, making the final decision.

There also are areas, such as RF transmitters, which cannot be easily harmonized. Each member state controls its own frequency spectrum so we are still faced with a country-to-country approach for approvals since no harmonized standards do, or most likely will ever, exist.

Myth #2–Only Competent Bodies through Technical Construction Files can approve a family of products.

Look at the first route to compliance in Figure 3. If you can apply the harmonized standards, you can self-certify. If you have a family of products, all of which you can apply the harmonized standards to, you can self-certify.

Read the Directive. Where does it tell you that you must test any product, let alone an entire product line? It doesn’t.

Remember, the basis for product approval is a manufacturer’s Declaration of Conformity. Accordingly, a manufacturer has a wide array of information he can use to support the fact that a product or a product family meets the essential requirements of the Directive.

Testing is one component, but so is the manufacturer’s engineering judgment. Engineering modeling and analysis, testing and similarity test data are all elements that a manufacturer can and should include in a Technical File supporting a Declaration of Conformity.

Myth #3–Using an EU-designated Notified Body will protect a manufacturer from liability.

Review the Directive, specifically the definition of manufacturer, and you will see that, in the eyes of the EU, the manufacturer assumes responsibility for the product. Europeans have gone to great pains to develop a manufacturer-friendly system.

The Declaration of Conformity and the ability to label their own products, are activities most manufacturers have always dreamed of. With that new-found approval freedom comes responsibility–responsibility which lies solely with the manufacturer.

The next time a Notified Body tells you that you should use him for an approval based on a manufacturer’s Declaration of Conformity, ask him if he will assume any liability for your product. You may be surprised by the answer.


I believe the European system is a good one and will get better with age. The EU has embarked on a course to totally revise the traditional approach to product approval.

Relying on manufacturers’ declarations and self-control through QA system registration and providing choices in routes to compliance are all new concepts that will take some time to work out. But it will happen.

Many EU directives and systems are just now being enforced and, as with any new systems, problems will arise. They will be addressed and issues such as consistency in Designation Bodies or consistency in opinions from one body to the next will be resolved.

You will see greater movement in our country to follow the European model. The latest FCC Notice of Proposed Rulemaking is a good example of what I mean. Harmonization of standards, testing and approvals will benefit all of us by minimizing our costs and increasing the potential for international trade.

About the Author

Walter A. Poggi is President of Retlif Testing Laboratories. He is active in several professional organizations, such as the American Council of Independent Laboratories, where he is Vice Chairman of the Government Relations Committee and the Conformity Assessment Section; the American Electronics Association and the American National Standards Association. Mr. Poggi earned a B.S. degree from the New York Institute of Technology. Retlif Testing Laboratories, 795 Marconi Ave., Ronkonkoma, NY 11779, (516) 737-1500.

Walter A. Poggi is President of Retlif Testing Laboratories. He is active in several professional organizations, such as the American Council of Independent Laboratories, where he is Vice Chairman of the Government Relations Committee and the Conformity Assessment Section; the American Electronics Association and the American National Standards Association. Mr. Poggi earned a B.S. degree from the New York Institute of Technology. Retlif Testing Laboratories, 795 Marconi Ave., Ronkonkoma, NY 11779, (516) 737-1500.

Copyright 1996 Nelson Publishing Inc.

January 1996

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