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Rules IVDD 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 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 in vitro diagnostic medical devices in accordance with Directive 98/79/EC. Please refer to "Rules - MDD" in the main index for further information on the rules for approval according to the Directive 93/42/EEC concerning medical devices. The Purpose of the New Rules for In Vitro Diagnostic Medical Devices What are In Vitro Diagnostic Medical Devices? Requirements for the Manufacturers The Purpose of the Classification Who Ensures that the Requirements Are Fulfilled? The Different Conformity Assessment Procedures
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