European Directives for Medical Devices
Medical Devices have to meet certain requirements before they are allowed on the European market. Those requirements are described in the European Directives for Medical Devices. The requirements regard the safety, performance and the environmental impact of the device for patient and user.
There are three Directives for Medical Devices: Active Medical Implants Directive (90/385/EEC) refers to devices such as pacemakers and other implants dependent on an energy source. Medical Devices Directive (93/42/EEC) refers to the largest group of products varying from wheelchair to heart valve. The third is the In Vitro Diagnostic Medical Devices Directive (98/79/EC). This directive holds for a large group of different products, varying from reagents and laboratory equipment to kits for use at home.
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