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IRIC safety alert

MHRA Medical Device Safety Information – MDSI2309

Published on 04 September 2023

From: Health Facilities Scotland

MDSI2309 - BioIntegral Surgical Inc. No-React® cardiovascular bioprosthesis implantables: discontinuation of CE marking and manufacture



BioIntegral Surgical ceased manufacturing in 2022 and withdrew the CE certification for all its products. MHRA advise that No-React® implantable cardiovascular devices already placed on to the UK market may continue to be sold and used. However, there is no manufacturer post-market surveillance and MHRA therefore emphasise the need to use national incident reporting systems.