Section one: Contracting authority
one.1) Name and addresses
Sheffield Teaching Hospitals NHS Foundation Trust
Royal Hallamshire Hospital, Glossop Road
Sheffield
S10 2JF
Contact
Kimberley Kay
Country
United Kingdom
NUTS code
UKE32 - Sheffield
Internet address(es)
Main address
Buyer's address
one.3) Communication
Additional information can be obtained from the above-mentioned address
Electronic communication requires the use of tools and devices that are not generally available. Unrestricted and full direct access to these tools and devices is possible, free of charge, at
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
Medical Devices for Research Project
Reference number
STH5238
two.1.2) Main CPV code
- 33100000 - Medical equipments
two.1.3) Type of contract
Supplies
two.1.4) Short 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 33195000 - Patient-monitoring system
two.2.3) Place of performance
NUTS codes
- UKE32 - Sheffield
two.2.4) Description of the procurement
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
two.2.14) Additional information
For further information and to register interest in this PIN, please contact Kimberley Kay kimberley.kay@nhs.net
two.3) Estimated date of publication of contract notice
15 November 2021
Section four. Procedure
four.1) Description
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes