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Product requirements of radiation equipment

Product requirements in general

In the European Internal Market, goods, services, equity, and people can move freely in accordance with common rules and principles. The unrestricted movement of goods is regulated by the European Economic Community (EEC agreement) and the so-called ‘new approach’ product Directives. The content of the Directives is transposed into the legislation of each member state.

If a product is demonstrated to fulfil all requirements within one member state, it can be put on the market everywhere within the internal market. However, the product shall be compliant with the harmonised rerquirements of the European Community. When the product is compliant with the essential requirements of the product Directives, the manufacturer attaches a CE mark on it indicating compliance. The manufacturer is able to show compliancy by complying with harmonised European standards. The titles of these standards relating to product Directives are published in the Official Journal of the European Communities.

If a product is not covered by any product Directive, the legislation of the individual member state is applied. In this case, the product can be brought onto the Internal Market through any member state, provided that the requirements of the state in question are fulfilled in accordance with the principle of reciprocal recognition.

Several product Directives do not require the use of harmonised standards. Products falling within ths scope of these directives can be demonstrated to comply with the essential requirements by other means.

Obligations of suppliers
Medical devices and accessories

Product control

Preliminary control and market control
On-site surveillance

Restrictions on use of radioactive substances in products

Page updated 19/09/2006