by TAISHA PAYTON
European Union (EU) released its long-awaited new directive on
electromagnetic compatibility (EMC) on December 15, 2004.1
Known as the Electromagnetic Compatibility Directive and also
called Directive 2004/108/EC, it repeals its predecessor, Directive
89/336/EEC, and provides new direction on the approximation of
the laws of the EU member states relating to EMC.2
Directive had been undergoing review by the European Commission
(EC) through an initiative known as SLIM, or Simpler Legislation
for the Internal Market. A final report showed that there was
a legitimate need to complete, reinforce, and clarify the framework
established by the 1989 EMC Directive.3
old EMC Directive will be repealed as of July 20, 2007. However,
products in compliance with the old directive may be placed on
the market until as late as July 20, 2009, two years after the
effective date of the revised directive.
states of the EU must adopt and publish laws, regulations, and
administrative provisions necessary to comply with the new EMC
Directive by January 20, 2007. Enforcement of the new administrative
provisions will begin on July 20, 2007.
of the Revised Directive
new EMC Directive is divided into four chapters. Between chapters
containing general provisions and final provisions are two chapters
on equipment: one describes apparatus and the other addresses
articles appear under the heading "General Provisions":
a treatment of the subject matter and scope of the directive;
definitions; placing equipment on the market and/or putting it
into service; the free movement of equipment; essential requirements;
and harmonized standards.
chapter on apparatus comprises an additional six articles. These
cover the conformity assessment procedure for apparatus; CE marking;
other marks and information; safeguards; decisions to withdraw,
prohibit, or restrict the free movement of apparatus; and notified
chapter called "Fixed Installations" comprises one article.
final chapter contains five articles, titled "Repeal,"
"Transitional Provisions," "Transposition,"
"Entry into Force," and "Addressees."
large and important changes mark this revised version of the EMC
Directive. The most notable involve fixed installations, the elimination
of competent bodies, and the use of harmonized standards.
Installations. Article 13 of the 2004 directive, which
is the complete chapter on fixed installations, is all new for
this edition. It basically says that apparatus placed on the European
market that is intended for a fixed installation is subject to
the requirements of the EMC Directive except for Articles 5 (Essential
Requirements), 7 (Conformity Assessment Procedure for Apparatus),
8 (CE Marking), and 9 (Other Marks and Information).
installations are defined to be "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." The issue of fixed installations
was not specifically addressed in the first EMC Directive, although
the technical construction file route to compliance was often
used for such installations.
a fixed installation creates electromagnetic disturbances, the
competent authorities of the concerned EU member state may ask
for proof of conformance or initiate an assessment, or both. If
noncompliance is established, the authorities can force the responsible
party to upgrade the fixed installation so that it complies with
the protection requirements.
More Competent Bodies. The use and definition of the
concept competent body has been deleted from the new
EMC Directive. In its place is a strengthened emphasis on notified
bodies (Article 12). This brings the EMC Directive into line
with other EU directives. The original version of the directive
was the only such document calling out competent bodies.
bodies must comply with the tasks referred to in Annex III of
the directive (see sidebar below).
the elimination of the competent body and the use of the notified
body in its place, the new EMC Directive emphasizes that conformity
assessment is the responsibility of the manufacturer, while still
allowing the manufacturer the option of using an independent third-party
conformity assessment body.
III: Conformity Assessment Procedure Referred to in Article
This procedure consists of applying Annex II [Conformity
Assessment Procedure Referred to in Article 7 (internal
production control)], completed as follows:
The manufacturer or his authorized representative
in the [European] Community shall present the technical
documentation to the notified body referred to in Article
12 and request the notified body for an assessment thereof.
The manufacturer or his authorized representative in the
Community shall specify to the notified body which aspects
of the essential requirements must be assessed by the notified
The notified body shall review the technical documentation
and assess whether the technical documentation properly
demonstrates that the requirements of the Directive that
it is to assess have been met. If the compliance of the
apparatus is confirmed, the notified body shall issue a
statement to the manufacturer or his authorized representative
in the Community confirming the compliance of the apparatus.
That statement shall be limited to those aspects of the
essential requirements which have been assessed by the notified
The manufacturer shall add the statement of the
notified body to the technical documentation.
Standards. The new EMC Directive places a renewed emphasis
on harmonized standards.
directive's Article 6 defines a harmonized standard as
"a technical specification adopted by a recognized European
standardization body under a mandate from the [European] Commission
in conformity with the procedure laid down in Directive 98/34/EC
[the Technical Standards and Regulations Directive4]
for the purpose of establishing a European requirement."
of equipment with a harmonized standard or standards that have
been published in the Official Journal of the European Union
shall raise a presumption of conformity with the essential requirements
in Annex I of the directive (see sidebar below).
references to national standards and their use for presumption
of conformity have been eliminated with the new EMC Directive.
In other words, the use of European harmonized standards is the
acceptable route for compliance purposes.
I: Essential Requirements
Referred to in Article 5
shall be designed and manufactured, having regard to the
state of the art, so as to ensure that:
the electromagnetic disturbance generated does not exceed
the level above which radio and telecommunications equipment
or other equipment cannot operate as intended;
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.
Specific requirements for fixed installations
and intended use of components
fixed installation shall be installed applying good engineering
practices and respecting the information on the intended
use of its components, with a view to meeting the protection
requirements set out in Point 1. Those good engineering
practices shall be documented and the documentation shall
be held by the person(s) responsible at the disposal of
the relevant national authorities for inspection purposes
for as long as the fixed installation is in operation.
9 of the new EMC Directive covers other marks and information.
This article imposes stricter product-identification
requirements on manufacturers than before, including clear indication
of the identity of the manufacturer, the agent for the manufacturer,
or the importer of the product into EU territory. This improved
product traceability will ease the regulatory authorities' task
of monitoring product conformance in the market.
addition to these substantive changes, the new version of the
EMC Directive introduces noteworthy clarifications and additional
requirements in the areas of scope, documentation, and the declaration
The new EMC Directive does not cover equipment covered by the
Radio and Telecommunications Terminal Equipment Directive. It
also does not cover aeronautical products, parts, and appliances.
Nor does it cover radio equipment used by radio amateurs within
the meaning of the radio regulations in the framework of the constitution
and convention of the International Telecommunication Union adopted
in 1992 and amended in 1994.
revised directive does not affect the applicability of legislation
promulgated by the EC or EU member nations that regulates the
safety of equipment.
of the articles in the new EMC Directive are similar to their
counterparts in the old directive. For example, Article 3 is basically
the same in both versions.
4 in the new directive covers material that was contained in Articles
5 and 6 of the old directive. However, it does add an allowance
for the display and demonstration of equipment not meeting the
requirements of the new EMC Directive at trade shows and exhibitions.
Equipment on such display must be accompanied by a visible sign
clearly indicating that the equipment must meet the EMC Directive
requirements before it can be placed on the market in the EU.
and Declaration. The subject matter of Annex IV of the
new directive includes technical documentation and the EC Declaration
documentation must enable the conformity of the apparatus with
the essential requirements to be assessed. It shall cover both the design and manufacture
of the apparatus. It must include the following elements:
A general description of the apparatus.
Evidence of compliance with the harmonized standards, if any,
applied in full or in part.
A description of the steps taken to meet the essential requirements
of the directive if harmonized standards were not followed.
A statement from the notified body whenever the procedure referred
to in Annex III has been followed.
Declaration of Conformity, under the revised directive, must contain
more than before, including at least the following:
A reference to the new EMC Directive.
An identification of the apparatus to which it refers, as set
out in Article 9(1).
The name and address of
the manufacturer and, where applicable, the name and address of
its authorized representative in the EU.
Dated references to the specifications under which conformity
is declared, to ensure recognition of the conformity of the apparatus
with the provisions of the directive.
The date of the Declaration.
Identification of the person empowered to bind the manufacturer
or its authorized representative, and that individual's signature.
are given a two-year transition period, from July 20, 2007, to
July 20, 2009, to continue legally to market equipment compliant
with the old EMC Directive in Europe. However, the new directive
does come into force in two years, and EU member states will have
legislation in place to support the new requirements at least
six months before that. Significant changes have been made in
the EMC Directive. Manufacturers would be well advised to familiarize
themselves soon with the changes and new requirements that have
been introduced, and to adjust their procedures accordingly.
"Directive 2004/108/EC of the European Parliament
and of the Council of 15 December 2004 on the approximation of
the laws of the Member States relating to electromagnetic compatibility
and repealing Directive 89/336/EEC," Official Journal
of the European Communities (OJ) no. L 390, December 31,
"Council Directive 89/336/EEC on the approximation
of the laws of the Member States relating to electromagnetic compatibility,"
OJ no. L 139, May 3, 1989.
Report of the SLIM III Team on the Electromagnetic
Compatibility Directive (89/336/EEC as amended), Final Version
(Brussels: European Commission, 1998).
"Directive 98/34/EC of the European Parliament and
of the Council of 22 June 1998 laying down a procedure for the
provision of information in the field of technical standards and
regulations," OJ no. L 204, July 21, 1998.
D. Hoolihan is president of EMC Consulting (Lindstrom, MN). He
can be reached at firstname.lastname@example.org.