On 08 July, the Medical Device Coordination Group (MDCG) published MDCG 2020-16 Rev. 3 guidance on “the classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746”. This document provides updates from the previous revision released in February 2023. These include:
- Addition of ‘kit’ definition
- Revision of examples for Rule 3(a) and Rule 6
- Revision of Rule 4(a) and Rule 5(c)
The primary purpose of this document is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union. It is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution.
