The European Union (EU) includes the following 27 Member States: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. These Member States differ in their constitutional and legal systems.

Where harmonization of legal requirements or administrative regulations is necessary, the European Commission -the executive body of the European Union- develops regulations, which after acceptance by the European Council, are called Council Directives or simply directives. Each directive describes the consensus that has been achieved and provides a deadline for the transposition of this consensus into the national laws of each Member State.

In 1985 a European Council Resolution on a new approach to technical harmonization and standards proposed a radical change in regulating the technical aspects of industrial products. The new approach involves the development of legislation specifying only the essential requirements that are general and mandatory. The detailed technical specifications that may be used to demonstrate conformity with the essential requirements are elaborated in voluntary harmonized standards.

Since 01 January 1993, the completion of the internal market has allowed free movement of goods throughout the territory of the European Union. A condition for such freedom of movement is the application of technical harmonization directives -also referred to as new approach directives- covering a wide range of industrial products such as machinery, personal protective equipment, medical devices, telecommunication terminal equipment, toys, in vitro diagnostic medical devices and so on.

The conformity assessment of a product or family of products may require the certification by a Notified Body as regulated in the respective directive. Lists of Notified Bodies, the tasks and responsibilities which have been assigned to them, and their unique four digit identification number is published and updated in the Official Journal of the European Communities.

If certification is a requirement as part of the conformity assessment procedure, the manufacturer has the option to choose any of the Notified Bodies in any of the Member States of the European Union.

If a product complies with the requirements of a new approach directive, the manufacturer marks it with the CE-mark. Products which require certification by a Notified Body carry the CE-mark in combination with the number of the Notified Body, for example: