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What is Criteria for Medical Devices about?

This document provides guidance on classifying medical devices with a measuring function under the EU Medical Devices Directives. [It outlines criteria for a device to be considered as having a measuring function: (1) it must measure a physiological parameter or substance delivery/removal quantitatively; (2) display the result in legal units; and (3) the intended purpose implies accuracy is important for patient health and safety. Examples of devices both with and without a measuring function are provided.]

Author

Mauro Costa

Language

EN