Application For The Use Of A Non UKCAmarked Device

application for the use of a non ukca-marked device on humanitarian grounds part 1 the manufacturer must complete this section

Application for the use of a non UKCA-marked device on humanitarian
grounds
Part 1
The manufacturer must complete this section
Name and address of supplier:
Email:
Telephone:
Name and address of manufacturer:
Generic name of device:
Number of identical/similar devices currently in use:
Details of any clinical investigations currently using device and
names of responsible or controlling authorities:
Details of aspects of device that differentiate it from other devices
already on the market:
Further information including a risk analysis, identification of
hazards, estimation of risks and how such risks have been addressed,
together with information to support a positive risk benefit analysis:
Signed: Date:
Name (printed):
Application for the use of a non UKCA-marked device on humanitarian
grounds
Part 2
The consultant must complete this section
Name and address of consultant:

Email:
Telephone:
Name of manufacturer:
Device to be used:
Name of patient: Date of birth:
Details of patient's medical condition:
Reason for device's necessity:
Consequence to patient's condition if device is not used:
Further information:
Declaration: It is my opinion that the patient's condition will
deteriorate without the use of the device named above and that there
is no other device available on the market that will fulfil the
function required. The patient has been informed of, and has
explicitly consented to his/her name, date of birth and medical
details being provided to the MHRA in this application for the purpose
of allowing the MHRA to assess the application under (choose 1
option):
 12(5) of the Medical Devices Regulations 2002, Part II – General
Medical Devices
 26(3) of the Medical Devices Regulations 2002, Part III – Active
Implantable Medical Devices
 39(2) of the Medical Devices Regulations 2002, Part IV – In Vitro
Diagnostic Devices
Signed: Date:
Name (printed):
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