Exceptional use of non complying devices

Approval can be sought to supply non-complying devices on humanitarian grounds.

Guidance has been prepared by MHRA for clinicians and manufacturers to help clarify how, and under what circumstances they may make applications to the Competent Authority (MHRA) for the use of a non CE-marked device for an individual named patient in the interest of  the protection of their health.

Application forms:

Directive Word form pdf form
IVD form (34Kb) form
MDD form (34Kb) form
AIMD form (36Kb) form


Completed forms should be sent or faxed to John Farquharson at:

Medicines & Healthcare products Regulatory Agency
Compliance Unit
8 Floor
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Fax: 020 7084 3112


Page last modified: 07 February 2008