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Safety Action Notice - 25 February 2019

Published on 16 September 2020

From: Health Facilities Scotland

SAN(SC)18/03 NHS Boards/local authorities exemption to new in vitro diagnostic medical device regulation (IVDR) and medical device regulation (MDR)



NHS Boards and local authorities may come within scope of the new in vitro diagnostic and medical device regulations. MHRA is consulting stakeholders who may be eligible to apply for exemption. To get the best range of views and allow health institutions to test and model the guidance, MHRA’s consultation will run for over 12 months and is not scheduled to close until 31st March 2019.