EU: European Commission’s Latest Updates to Borderline & Classification Manual

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

For the manual please click here: Manual on Borderline and Classification – Version 1.20.


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