Medical Device Regulatory Compliance Tender, United Kingdom - 108481638

Procurement Summary

Country : United Kingdom

Summary : Medical Device Regulatory Compliance

Deadline : 24 Oct 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 108481638

Document Ref. No. : CF-2645300D0O000000rwimUAA

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : GBP 110000

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Tender Details

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-proc...
Location Of Contract : LS1 4AP
Industry : Repair and maintenance services of medical and surgical equipment - 50420000 System quality assurance assessment and review services - 72225000
Value Of Contract : £110, 000
Published Date : 10 October 2024
Closing Date : 24 October 2024

Documents

 Tender Notice