dimarts, 27 de novembre del 2018

EU updates Borderline and Classification manual

Emergo GroupBy Ronald Boumans, Emergo Group

On October 30, 2018 the European Commission published the most recent version of the Borderline & Classification Manual. This document provides guidance on establishing the status of medical devices and IVDs, as well as their risk classifications. The current version, version 1.20 replaces version 1.19 released in April 2018.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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