Information Document Concerning the Definition of the Term “Medical Device” and IVD

Titel:
Information Document Concerning the Definition of the Term “Medical Device” and IVD
Herkunft/Verlag:

GHTF

Inhalt:
This document is intended to provide harmonized definitions of the terms ‘medical device’ and ‘In Vitro Diagnostic (IVD) medical device’. Bodies and industry, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the control of medical devices in the interest of public health. It seeks to strike a balance between the responsibilities of Regulatory Authorities to safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens upon the industry.

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