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



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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