The New EMC Directive - 2004/108/EC

A summary of the differences between the new EMC Directive (2004/108/EC) and the old EMC directive (89/336/EEC)

General

The EMC directive 89/336/EEC has been subject to a review under the initiative known as Simpler Legislation for the Internal Market (SLIM). The directive now covers both fixed installations and apparatus; separate provisions should be made for each of these. The directive does not regulate equipment that is inherently benign in terms of electromagnetic compatibility.

Transitional provisions and implementation

Equipment that complies with directive 89/336/EEC can be placed on the market until 20th July 2009.

All member states must adopt and publish the laws and make the administrative provisions necessary to comply with this directive by 20th January 2007. They shall apply those provisions from 20th July 2007.

The directive is applicable to finished apparatus commercially available for the first time on the community market.

Fixed installations

The directive will cover fixed installations, large machines and networks which may generate electromagnetic disturbance or be affected by it.

It should be possible to use harmonised standards to demonstrate conformity with the essential requirements.

Due to the nature of fixed installations, placing the CE mark on the equipment and creating a Declaration of Conformity are not required.

Apparatus

The directive now states where apparatus is capable of taking different configurations, the EMC assessment should take into account the different configurations foreseeable by the manufacturer as representative of normal use in the intended applications. Certain components or sub-assemblies should, under certain conditions, be considered to come under the directive if they are made available to the end user.

Marking

The directive has clarified the marking requirements. The apparatus must now be identified in terms of type, batch, serial number or any other information allowing for the identification of the apparatus. Each apparatus must carry the name and address of the manufacturer, or agent, or the person placing the equipment on the community market.

Information shall be provided on any specific precautions to be taken when the equipment is assembled, installed, maintained or used to ensure that when the equipment is put into service conformity is still achieved. All information required to enable the apparatus to be used in accordance with the intended purpose must be contained in the instructions. Clear indication of any restriction of use shall be on the packaging.

Essential requirements

The essential requirements have not changed. However, requirements for fixed installations have been included. Good engineering practices should be used and documented, the documents shall be held available for the relevant national authorities for as long as the fixed installation is in operation.

Conformity assessment procedure for apparatus

The directive now has two methods to demonstrate compliance for apparatus, they are listed below;

1. Internal production control (more commonly known as 'self-certification')

2. Internal production control and inspection by a Notified Body

Internal production control (Annex II)

The manufacturer shall perform an EMC assessment of the equipment on the basis of the individual relevant phenomena with a view to meeting the essential requirements of the directive.

The application of the correct relevant harmonised standards as published in the Official Journal, shall be the equivalent to the EMC assessment. The assessment must take into account the different configurations and operating conditions to be expected in the normal operating conditions.

The manufacturer shall draw up technical documentation providing evidence of the conformity of the apparatus with the essential requirements of the directive. The manufacturer must take all measures necessary to ensure the products are manufactured in accordance with the technical documentation and confirm to the directive.

Use of a Notified Body (Annex III)

At the discretion of the manufacturer or the authorised representative the method below can also be used to demonstrate compliance;

1. The internal production control method should be applied

2. The technical documentation should be presented to the Notified Body. The manufacturer or authorised representative shall specify which aspects of the essential requirements are to be assessed by the notified body.

3. The notified body shall review the documents and assess if the documents demonstrate that the requirements of the directive have been met. If compliance is confirmed the notified body will issue the manufacturer or agent a statement confirming this. The statement should be limited to the aspects which have been assessed by the notified body.

4. The statement should be added to the technical documents.

Technical Documentation

The technical documentation required by the directive must enable the conformity of the equipment to be assessed - it should cover the design and manufacture of the equipment.

The documents should include the following information;

1. A general description of the equipment.

2. Evidence of compliance with the harmonised standards where applied.

3. Where the harmonised standards have not been applied or only partly applied, a description and explanation of the steps taken to meet the requirements of the directive should be included. This must include the EMC assessment, design calculations, examinations performed and test reports.

4. A statement from the notified body (if used).

EC Declaration of Conformity

The requirements for the EC declaration of Conformity have altered. It now should contain the following information:

1. Reference to this Directive.

2. The identification of the equipment.

3. The name and address of the manufacturer and, where applicable, the authorised representative in the community.

4. A dated reference to the standards used to support a claim of compliance

5. The date of the declaration.

6. The identity and signature of the person empowered to sign the declaration.