---
title: "New Revision to MDCG 2020-16 Guidenance Document Released"
description: "On March 18th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR). This fourth revision focuses on devices to detect infectious agents, particularly SARS-CoV-2."
url: https://qbdgroup.com/en/regulatory-updates/new-revision-to-mdcg-2020-16-guidenance-document-released
type: "Regulatory update"
language: en
published: 2025-04-23
author: "Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"New Revision to MDCG 2020-16 Guidenance Document Released\", https://qbdgroup.com/en/regulatory-updates/new-revision-to-mdcg-2020-16-guidenance-document-released"
---
# New Revision to MDCG 2020-16 Guidenance Document Released
> On March 18th, 2025, the Medical Device Coordination Group (MDCG) released a new revision of its guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (IVDR). This fourth revision focuses on devices to detect infectious agents, particularly SARS-CoV-2.

This fourth revision of MDCG 2020-16 focuses on devices to detect infectious agents, and in particular SARS-CoV-2.

## What is new?

The fourth revision of MDCG 2020-16 is a consequence of the [scientific advice on SARS-CoV-2](https://qbdgroup.com/en/regulatory-updates/expert-panel-advice-on-sars-cov-2) issued by EMA’s IVD expert panel in late January 2025, and reclassifies devices to detect SARS-CoV-2. Such devices are no longer regarded as Class D under Rule 1, 2nd indent (devices intended to be used for the detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation), but instead are classified as Class B under Rule 6 (devices not covered by Rules 1-5) when not intended for self-testing.

The guidance clarifies that the classification of devices to detect certain moderate-risk infectious agents is not set in stone. In case of changes in the epidemiological context, such as a new strain of an infectious agent, the risk to the individual or public health may change and classification rules 1 or 3 could become applicable and the class of the device revised.

Further, the guidance re-affirms the Class C designation of most devices intended for self-testing by listing self-testing devices intended for the detection of SARS CoV-2 or antibodies against SARS CoV-2 as examples under Rule 4(a).

## What does it mean to you?

MDCG 2020-16 Rev.4 is important for manufacturers of devices to detect (solely or amongst others) SARS-CoV-2. Annex XIII of the Common Specifications (Regulation (EU) 2022/1107) no longer applies to such devices as detection of SARS-CoV-2 no longer belongs to risk Class D. Also, detection of SARS-CoV-2 no longer requires devices to undergo performance verification and batch release testing by EU reference laboratories.

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---
Source: https://qbdgroup.com/en/regulatory-updates/new-revision-to-mdcg-2020-16-guidenance-document-released — © QbD Group. Quote freely with attribution and a link back.