4 docs tagged with "special-access"

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.

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.

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.

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.