Article summary
The European Association of Medical devices Notified Bodies (Team-NB) has announced on 4 April 2025 that COVID-19 tests will be reclassified from Class D to Class B or C under updated Medical Device Coordination Group (MDCG) guidance 2020-16 Rev.04. The change follows expert panel advice that SARS-CoV-2 no longer poses a life-threatening risk to the European population. The reclassification removes requirements for batch verification, EU Reference Laboratory testing, and mandatory Common Specifications compliance. Team-NB advises affected manufacturers to contact their notified bodies regarding certification implications.
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