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.
From: Medicines and Healthcare
products Regulatory Agency
Documents
List of medical devices
given exceptional use authorisations
List of medical devices
that are no longer covered by an exceptional use
authorisation
Details
To ensure transparency around the supply of medical devices in
the UK, we are now providing a list of manufacturers and devices
granted an exceptional use application. We also provide a list of
recently expired. withdrawn or cancelled authorisations for a 2
month period.
Medical devices granted an exceptional use authorisation can be
sold to the NHS and within the social care setting to ensure a
continued supply of medical devices.
Exceptional use authorisations will be issued directly to the
manufacturer of the medical device and normally do not allow for
distributor sales.
We only consider
applications where there is a clear clinical need and there
is no available supply of CE marked or already derogated
alternatives.
An updated list (if there are any changes to report) will be
published weekly to reflect any new, withdrawn or expired
applications.