Published date: 10 October 2024
Closed opportunity - This means that the contract is currently closed. The buying department may be considering suppliers that have already applied, or no suitable offers were made.
Contract summary
Industry
Repair and maintenance services of medical and surgical equipment - 50420000
System quality assurance assessment and review services - 72225000
Location of contract
LS1 4AP
Value of contract
£110,000
Procurement reference
CF-2645300D0O000000rwimUAA
Published date
10 October 2024
Closing date
24 October 2024
Closing time
12pm
Contract start date
25 October 2024
Contract end date
28 November 2025
Contract type
Service contract
Procedure type
Open procedure (below threshold)
Any interested supplier may submit a tender in response to an opportunity notice.
This procedure can be used for procurements below the relevant contract value threshold.
Contract is suitable for SMEs?
Yes
Contract is suitable for VCSEs?
Yes
Description
There are currently 5 Software medical devices (SaMD) products registered with the MHRA with NHSE as the legal manufacturer. These products are classified as the lowest risk class-Class 1 devices under the current Medical device regulation (UK MDR 2002). However, the regulation is currently being revised and the amended regulation will be published in July 2025 by the MHRA. The new updated regulation is expected to be stricter with tougher compliance requirements on the legal manufacture.
We therefore need to update NHSE software medical device products' testing, validation and technical documentation to bring the products in line with the expected requirements of the amended regulation. This work needs support from Clinical safety officers (CSOs) who are also well versed with medical device regulation.
A full description of the requirement can be found in the ITQ document once suppliers have registered their interest.
Please note: the budget for this work is £110,000 exclusive of VAT.
Interested suppliers should register on the NHS England e-procurement system here: https://health-family.force.com/login
• Once logged in click 'Find Opportunities' and search for 'Medical device regulatory compliance'
• Click 'Register Interest'
• Once you have registered your interest you will be able to view the Requirements and submit a response to the questions within the portal.
• Any messages about the opportunity should be sent via the e-procurement system. You can do this by going to the home page and:
o Click on 'My proposals & Quotes'
o Click the relevant Project Title
o Click 'Messages' & 'New Message'
More information
Additional text
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To express interest and participate in the tender, please register and apply via Atamis e-sourcing portal https://health-family.force.com/s/Welcome.
Should Tenderers have any queries, or having problems using the portal, they should contact Helpdesk at:
Phone: 0800 9956035
E-mail: support-health@atamis.co.uk
About the buyer
Contact name
NHSE Commercial
Address
7-8 Wellington Place
Leeds
LS1 4AP
United Kingdom
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Closing: 24 October 2024, 12pm
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