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
5th Floor
151 Buckingham Palace Road
London
SW1W 9SZ UK
Fax: 020 3118 9809
