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Rules - MDD As part of the implementation of the European single market three Directives on medical devices have been prepared. The first Directive, which concerns active, implantable devices (eg pacemakers), became effective on January 1, 1993. The second Directive (the general Directive), which covers all medical devices except from active, implantable medical devices and in vitro diagnostic devices, became effective on January 1, 1995. The third Directive on in vitro diagnostic medical devices (eg laboratory equipment) was adopted by the Council of the European Union in October, 1998. On the following pages further information is provided on the rules for approval of medical devices in accordance with the general Directive (93/42/EEC). Please refer to "Rules - IVDD" in the main index for further information on the rules for approval according to the Directive concerning in vitro diagnostic medical devices 98/79/EC. The Purpose of Directives Requirements for the Manufacturers Who Ensures that the Requirements Are Fulfilled? The Different Conformity Assessment Procedures Manufacturer and Product Registration Devices in the Distribution System after June 14, 1998 Implications of the Directives
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