Guidance MDCG on classification for IVD MD under Regulation (EU) 2017/746

The Medical Devices Coordination Group (MDCG) has published a Guidance document MDCG 2020-16 on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.

After a brief reminder of applicable definitions and principles of classification, the guidance document explains each IVDR classification rules illustrated by examples.

As a reminder, the class of the device determines the conformity assessment procedure choice. For manufacturers of in-vitro diagnostic medical devices, this is one of the first pieces of information to verify in order to confirm their strategy for transitioning towards the Regulation.

DOWNLOAD THE GUIDANCE MDCG 2020-16