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.