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Medical Device Regulatory Compliance

Reference ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09 · NHS England

Closed. Submission deadline: 24 October 2024. Estimated value: £110,000.

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Amounts and figures

£110,000
Estimated value

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 'Me…

Official publications

MediumReferenceDate
FTS be6f5aa4-37ba-4778-9da0-70b951797890-793013 10 October 2024
Contracts Finder be6f5aa4-37ba-4778-9da0-70b951797890-793013 10 October 2024

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Frequently asked questions

What is the deadline to bid for this tender?
The submission deadline is 24 October 2024, 12:00. Check the official source, as dates can be modified.
What is the estimated value of this tender?
The estimated value published by the buyer is £110,000.
Who is the buyer of this tender?
The contracting authority is NHS England (United Kingdom).
How can I bid for public tenders in the United Kingdom?
Bids are submitted through the official public procurement portal in the United Kingdom. El Vínculo helps you find tenders and analyse their documents; submission always happens at the official source.

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Data collected from official public procurement sources. Amounts as published by the buyer.