By 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.
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