Exceptional Use Authorisations (EUA)
MHRA's Exceptional Use Authorisation mechanism — when MHRA can authorise the use of an unlicensed or non-UKCA-marked device in exceptional circumstances, including public health emergencies.
Approved for Use designations
MHRA's "Approved for Use" designation mechanism — what it is, how it differs from standard market authorisation, and the conditions under which MHRA can grant this status.
Clinical investigations — access pathways
How investigational medical devices can be used in clinical investigations in the UK before full conformity assessment — MHRA notification, ethics requirements, the investigational device exemption, and special access provisions for participants.
Custom-made device exemption
How the custom-made device exemption from standard conformity assessment works under the UK MDR 2002 — who qualifies, what obligations remain, and the limits of the exemption.