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Hearing Day 64 Evidence

Evidence Information
Submission date: 15th Oct 2026
Hearing: Hearing Day 64 – October Hearing (2026)
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Submission date: 15th Oct 2026

Available Documents (18)

OXHE005087_LC3.7 Oxevision Activity Tracker IFU Version 5 (PDF: 33.68 MB)
ONLINE SOURCE Regulation 2 of the Medical Devices Regulations 2002 (PDF: 8.02 MB)
NHSE028974_PS015 Email to NHSE Mental Health team sharing NRLS report following meeting (PDF: 1.78 MB)
NHSE028965_PS013 Oxehealth response to MHRA Questions (PDF: 8.31 MB)
NHSE028957_PS014 Emails between NHSE and MHRA regarding Oxevision responses (PDF: 3.93 MB)
NHSE028936_PS012 Email from MHRA to NHSE re questions for Oxehealth (PDF: 3.03 MB)
MHRA028127_First Witness Statement of Robert Reid on behalf of MHRA (PDF: 23.17 MB)
MHRA028025_Second Witness Statement of Robert Reid (PDF: 4.46 MB)
MHRA025474_RR1-1 Email chain requesting the Instruction For Use material for Oxehealth devices (PDF: 8.66 MB)
MHRA025471_RR1-12 MHRA emails regarding Oxevision activity tracker (PDF: 9.59 MB)
MHRA025464_RR1-13 Email chain between Oxehealth Chris Hannan and MHRA Hafsa Sirad regarding medical device qualification (PDF: 11.12 MB)
MHRA025461_RR1-17 MHRA No Objection letter signed by Heloise Mignot (PDF: 7.04 MB)
MHRA025447_RR1-2C Oxehealth Declaration of Conformity according to Medical Devices Directive (PDF: 1.04 MB)
MHRA025443_RR1-3A NHS NRLS analysis summary regarding oxehealth and oxevision (PDF: 15.11 MB)
MHRA025435_RR1-5A Oxehealth Response to MHRA Questions (PDF: 15.71 MB)
MHRA025425_RR1-7 Internal MHRA emails regarding Oxehealth advertising material (PDF: 2.31 MB)
MHRA025423_RR1-9 Internal MHRA email chain regarding reportable incident on Oxehealth (PDF: 3.73 MB)
BSI028561_Witness Statement of Graeme Tunbridge (PDF: 33.84 MB)
Related hearings

Hearing Day 64 – October Hearing (2026)

Hearing type: Public Hearing
15th Oct 2026
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Evidence Information
Hearing: Hearing Day 64 – October Hearing (2026)
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