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Team-NB announces changes to COVID test classification under MDCG guidance

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Published on: 07 April 2025

Published by LNB News

LNB News 07/04/2025

Document Information

Issue Date: 07 April 2025

Published Date: 07 April 2025

Jurisdiction(s): European Union

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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