PART B - Additional information for specific applications
Part B: Section 2 - Research using Medical Devices Medical devices (populates MHRA Devices forms)
IRAS question number
Subject Standard response to question or refer to information icon .
i .
in IRAS for guidance
Further JRO guidance / information
1-1
1-2
2
3-1
3-2
Device manufacturer / sponsor
Legal representative acting as
Authorised Representative
Details of medical device
Purpose of study
Further details of the device
.
i .
.
i .
.
i .
.
i .
.
i .
Provide instructions for use for CE marked products. This is normally obtainable from the manufacturer of the device.
NB. The letter of no objection from the MHRA for the clinical investigation of a non-CE marked medical device or a CE marked medical device being used for a new purpose is required for device studies.
Additional information for notifications to the Competent Authority
IRAS question number
Subject Standard response to question or refer to information icon .
i .
in IRAS for guidance
Further JRO guidance / information
Investigators guide to responding to IRAS questions Version 1, 16 May 2013 1

1
2
3
4
5
6
7
8-1
8-2
9
10-1
10-2
10-3
C
1 st submission / re-submission to MHRA
CA fee payable to CA
Approval of Notified Body quality system or process
Class of device
Details of other countries
UK/Global number of devices
Single / multi-site study
ENISO14155 compliance
Contact person / details
Additional Investigators (other than CI)
Substance or human blood derivative
Regulation under AIMDD
2007/47/EC
Utilising tissues of animal origin
Sterilisation annex(es)
Summary of information for notifications to the Competent Authority
IRAS question number
Subject Standard response to question or refer to information icon .
i .
in IRAS for guidance
1 Application to REC
Investigators guide to responding to IRAS questions Version 1, 16 May 2013
Further JRO guidance / information
2

2-1
2-2
2-3
2-4
2-5
Active medical device
Is device implanted or invasive?
Device sterilisation
Animal studies
Device software
1
2
3
Sterilisation related questions
IRAS question number
Subject
Name of device or component
Single / re-use of device
Sterilisation of device
Standard response to question or refer to information icon .
i .
in IRAS for guidance
Further JRO guidance / information
Investigators guide to responding to IRAS questions Version 1, 16 May 2013 3