of 14 June 1993 concerning medical devices
1 . This Directive shall apply 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. Whereas, in the fight against AIDS and in the light of the conclusions of the
2 . For the purposes of this Directive, the following definitions shall apply:
(a ) 'medical device' means any instrument, apparatus, 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, Read more ...


 

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