New Revision to MDCG 2020-16 Guidenance Document Released

What is new?

The fourth revision of MDCG 2020-16 is a consequence of the scientific 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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