Medical Devices for Research Project

Description

Procurement is required for supply of: Transcutaneous Vagal Nerve stimulator medical devices, with facility to accommodate activation via wrist activity band, with associated CE (and to follow UKCA/UKNI) marking. Lot 1: 1. The 1st Device MUST be a CE Marked Transcutaneous Vagal Nerve Stimulation (TVNS) Class IIa Medical device, Registered in accordance with EU regulation for medical devices 2017/745 MDR Annex VIII.2. MUST have the facility of TVNS to interact and be activated by an activity wristband.3. The 2nd Device MUST be a CE Marked Activity Wristband which has the ability to interact with the Device 1 TVNS device, and also record daily activities.4. Both Devices MUST be CE Marked and when used in conjunction (intentions to apply for UKCA and UKNI marks when required)5. Must be able to order 75-100 of both devices. 6. Devices to be provided MUST without exchange of clinical data to change market authorisation7. MUST be able to supply the requirement within 3 months of the order being placed. THE DEADLINE TO RESPOND IS 28/10/2021 AT 12PM. Additional information: For further information and to register interest in this PIN, please contact Kimberley Kay kimberley.kay@nhs.net