Technology International (Europe) Ltd

EMC Directive Compliance

Frequently Asked Questions

1. When does the new EMC Directive come into force?
2. What if my product was placed on the market before 20th July 2007?
3. If my product was placed on the market before 20th July 2007 what must I do by 20th July 2009?
4. How do I demonstrate compliance to the new EMC Directive?
5. Does the new EMC Directive include a requirement for third party assessments?
6. Who is qualified to undertake third party assessments?
7. Do the European Product Standards for EMC change at the same time as the Directive?
8. Will I need to retest my product to meet the new Directive?
9. What is the role of a Notified Body?
10. When should a Notified Body be used?
11. When should I use the Technical File Route to demonstrate conformity?
12. How do I know an EMC Assessment is adequate?
13. How do I deal with design changes to products certified under the old EMC Directive?
14. Do I always have to prepare compliance documentation for the new EMC Directive?

When does the new EMC Directive come into force?

The new EMC Directive (2004/108/EC) comes into force on the 20th July 2007. All products 'placed on the market' or 'brought into service' within the European Union that fall within its scope must comply with the requirements of the new Directive from that date onwards.

What if my product was placed on the market before 20th July 2007?

If a product or system was placed on the market or brought into service prior to the 20th July 2007 it should comply with the existing EMC Directive, 89/336/EEC. Declarations of Conformity to EMC Directive 89/336/EEC will remain valid until 20th July 2009.

If my product was placed on the market before 20th July 2007 what must I do by 20th July 2009?

If the product was certified using the "Standards Route", any Declarations of Conformity made under the old Directive 89/336/EEC are valid until 20th July 2009. A Declaration of Conformity to the new Directive 2004/108/EC should be issued on or before 20th July 2009.

If the product was certified using the "Technical Construction File (TCF) Route",you should contact an EMC Notified Body to discuss options for modifying the existing TCF to ensure continuing compliance.

How do I demonstrate compliance to the new EMC Directive?

By completing an "EMC Assessment", either by applying and testing in full to Harmonised EMC Standards (aka 'The Standards Route'), or by preparing a Technical File (the 'Technical File Route'),and providing sufficient evidence that a product meets the essential requirements of the new Directive.

Does the new EMC Directive include a requirement for third party assessments?

Third party assessments are voluntary under the new EMC Directive. It may however, remain either common practice or a regulatory requirement within certain industry sectors (e.g. railway infrastructure operators) for manufacturers’ EMC Compliance Documentation to be subjected to assessment by a qualified third party.

Who is qualified to undertake third party assessments?

Notified Bodies for the EMC Directive, appointed by individual governments of the European member states, are the only organisations authorised to conduct third party assessments. (See Question 9 below for more information)

Do the European Product Standards for EMC change at the same time as the Directive?

No, European Product Standards are periodically updated independently of the Directive.

Will I need to retest my product to meet the new Directive?

Assuming the Standards applicable to your equipment remain unchanged, no re-testing is required specifically as a result of the new Directive.

What is the role of a Notified Body?

The purpose of a Notified Body is to help the manufacturer (or his authorised representative within the Community) ensure that their products meet the essential requirements of the EMC Directive by reviewing the technical documentation that has been drawn up. It is an important and valuable service, which reduces the risk of a manufacturer’s claim of conformity being challenged at a later date.

When should a Notified Body be used?

A manufacturer may voluntarily choose to employ a Notified Body to review Technical Documentation in order to give additional confidence to a claim of conformity to the EMC Directive. Alternatively a manufacturer’s customers or the relevant regulatory authorities may make a review of Technical Documentation by a Notified Body mandatory for specific products or types of product.

When should I use the Technical File Route to demonstrate conformity?

Generally, Technical Files can be used to demonstrate conformity for the following reasons:

• A product is too large or complex to be fully tested strictly in accordance with the requirements of applicable harmonised standards
• No harmonised standards exist which are applicable to the product
• Where a range of equipments having similarity with a tested (or partially tested) example need to be covered
• Where a product is to be introduced into an EMC environment for which it was not originally designed

How do I know an EMC Assessment is adequate?

You don't. If an EMC Assessment has been completed by ensuring a product passes tests to ‘harmonised standards’ (i.e. the Standards Route) it is normally assumed that this demonstrates conformity with the requirements of the Directive. This may not however, be true in all circumstances. Having a Notified Body conduct a formal review of the supporting documentation for an EMC Assessment will provide definitive confirmation of its adequacy.

How do I deal with design changes to products certified under the old EMC Directive?

If the product was certified to the old Directive using the ‘Standards Route’ an entirely new EMC Assessment to the requirements of the new Directive will need to be completed.

If the product was certified to the old Directive using the ‘Technical Construction File Route’ and the TCF has been converted into a Technical File (see Question 3 above) the existing File can be amended to address any changes. If a Notified Body assessed the conversion from TCF to TF all amendments to the File should also be assessed to ensure continued compliance.

Do I always have to prepare compliance documentation for the new EMC Directive?

Yes, a manufacturer needs to draw up technical documentation which provides evidence of conformity of the apparatus with the essential requirements of the new Directive. This technical documentation must cover the design and manufacture of the apparatus, and for example may include:

• A general description
• Evidence of compliance with harmonised standards (i.e. a copy of the test reports)
• Where the manufacturer has not applied harmonized standards, or has applied them only in part, a description and explanation of the steps taken to meet the essential requirements of the Directive
• When applicable, a statement from a Notified body