Direntive 93/42/EEC applies to medical devices and their accessories that fit the following definitions
Medical devices
Any instrument,apparatues,appliance,material or other article,whether used alone or in combination,including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis,prevention,monitoring treatment or alleviation of disease,
- diagnosis,prevention,monitoring,treatment of alleviation of or compensation for an injury or handicap,
- investigation,replacement or modification of the anatomy or of a physiological process,
- control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological,immunological or metabolic means,but which may be assisted in its function by such means.
Accessory
Any article which,whilst not a device is intended specifically by its manufacturer to be used with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.
The directive does not apply to :
- in-vitro diagnostic devices,
- active implantable devices covered by directive 90/385/EEC,
- medicinal products covered by the directive 65/65/EEC,
- cosmetic products covered by directive 76/768/EEC,
- human blood,human blood products,human plasma or blood cells of human origin or to devices which incorporation at the time of placeing on the market such blood products,plasma or cells,
- transplants or tissues or cells of human origin nor to products incorporation or durived from tissues or cells of human origin,
- transplants or tissues or cells of animal origin,unless a device is manufactured using animal tissues which is rendered non-viable or non-viable products derived from animal tissues.