Please note this is an extract of the original bulletin.
Medical devices given exceptional use authorisations during the COVID-19 pandemic
Page summary:
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.
Change made:
Updated open & closed lists.
COVID-19 test validation approved products
Page summary:
Find out which COVID-19 test products have been approved.
Change made:
Updated ‘COVID-19 test validation approved products’ to July 2023.
Borderline products: how to tell if your product is a medical device and which risk class applies
Page summary:
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Change made:
An additional section ‘Annex A – MHRA borderline determinations’ has been added to assist manufacturers to arrive at the appropriate classification for their products.
