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MHRA (UK)
Original article

Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)

RegulatoryNegative
AI Analysis

Summary

The MHRA issued a regulatory alert (DSI/2026/007) regarding medical devices being supplied on the UK market without valid UKCA/CE conformity markings or certification in violation of UK and EU medical device regulations. Affected devices must be removed from use and placed in quarantine.

Outcome Details

MHRA alert regarding medical devices supplied without valid UKCA/CE conformity markings or certification; devices must be removed from use and quarantined

Importance:6/10
Sentiment:
-0.70
regulatory_alertmedical_devicesUKCACE_markingcomplianceUK_MDREU_MDR
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Published by MHRA (UK) on August 10, 2026 1:00 PM

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