This article gives an introduction to the main elements of the European Medical Devices Directive.
OFFICIAL TITLE
Council Directive 93/42/EEC of 14 June 1993 on the approximation of the laws of the Members States relating to medical devices.
The complete text of the Medical Devices Directive has been published in the Official Journal of the European Communities No. L 169, of 12 July 1993.
AMENDMENTS TO THIS DIRECTIVE
Directive 98/79/EC, OJ 331 of 07/12/98
OBLIGATORY SINCE
The Medical Devices Directive is obligatory since 14 June 1998
(Transitional period for clinical mercury-in-glass, maximum reading thermometers: until 1 July 2004.)
SCOPE OF THE MEDICAL DEVICES DIRECTIVE
This Directive applies to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.
EXCLUDED FROM THE SCOPE OF THE DIRECTIVE
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devices for in vitro diagnostics (separate CE Directive)
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active implantable medical devices(separate CE Directive), except for the general provisions
REQUIREMENTS OF THE MEDICAL DEVICES DIRECTIVE
The Medical Devices Directive sets essential requirements for the safety of medical devices. These requirements can be subdivided into the following categories:
MAIN OBJECTIVE
The main objective of the Medical Devices Directives is the protection of the health and safety of persons, and thus to prevent, as far as possible, the placing on the market and putting into service of unsafe or otherwise non-compliant products.
CONFORMITY MARKING
Conformity with the Medical Devices Directive is indicated with the CE Marking, which is a mandatory marking for products falling within the scope of this Directive. CE stands for Conformité Européenne, French for European conformity.
Without the CE Marking, and thus without complying with the provisions of the Directive, the product may not be placed on the market or put into service in the European countries that form the European Economic Area (the EEA consists of the fifteen member states of the EU and Norway, Iceland and Liechtenstein.) However, if the product meets the provisions of the applicable European Directives these countries may not prohibit, restrict or impede the placing on the market or putting into service of the product.
Thus, the CE Marking can be regarded as the products trade passport for Europe.
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