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18 March 2025Background
In February 2024, Team Notified Body published a Position Paper recommending down-classifying SARS-CoV-2 devices from Class D (highest risk).
In January 2025 the IVD Expert Panel published scientific advice on the subject:
“…while the virus can still cause serious illness, it no longer poses a life-threatening risk with a significant mortality rate for the general European population.”
“…MDCG guidance on IVD classification (MDCG 2020-16) is being updated to reflect this advice.“
The Update
MDCG 2020-16 (March 2025; revision 4) is available: HERE
SARS-CoV-2 tests have been down-classed from Class D, under Rule 1, second indent, to:
- Layperson SARS-CoV-2 self-tests are now Class C, under Rule 4(a)
- Professional-use SARS-CoV-2 tests are now Class B, under Rule 6
Additionally, footnote 8 was edited to remove a link.
NOTE: MDCG guidance documents are technically legally non-binding. However, while they cannot be enforced in court, most stakeholders, including manufacturers, notified bodies, and competent authorities, are expected to follow them to ensure consistent application of the regulations.
