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 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.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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