Search results with tag "Medical devices guidance document classification of"

MEDICAL DEVICES Guidance document Classification of ...

3.1. Basic definitions The classification rules are based on different criteria such as the duration of contact with the patient, the degree of invasiveness and the part of the body affected by the use of the device. Intended purpose is defined in Article 1 paragraph 2(g) of Directive 93/42/EEC. The other terms are defined in chapter I section 1 of

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