Tender

Medical Device Regulatory Compliance

NHS ENGLAND

This public procurement record has 1 release in its history.

Tender

10 Oct 2024 at 15:17

Tender Notice
Summary of the contracting process

NHS England is currently in the Tender stage for a public procurement process titled "Medical Device Regulatory Compliance," focusing on the services industry. This tender addresses the need to update software medical devices' testing, validation, and technical documentation to comply with the upcoming stricter regulations set to be published by the MHRA in July 2025. The deadline for tender submissions is 24th October 2024, with the contract period commencing on 25th October 2024 and concluding by 28th November 2025. The total budget allocated for this project is £110,000 exclusive of VAT. The procurement method is an open procedure, targeting small and medium enterprises (SMEs) as well as voluntary, community, and social enterprises (VCSEs).

This tender provides ample opportunities for businesses that specialise in regulatory compliance, quality assurance, and medical device maintenance. Companies with expertise in Software as a Medical Device (SaMD) and clinical safety officers proficient in medical device regulations will find this project particularly suited to their capabilities. By participating, businesses can not only expand their portfolio but also position themselves as key players in ensuring compliance with evolving medical device regulations, thereby fostering growth and establishing credibility in the healthcare sector.

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Notice Information

Notice Title

Medical Device Regulatory Compliance

Notice 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 PS110,000 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' Additional information: 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

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/be6f5aa4-37ba-4778-9da0-70b951797890
Current Stage
Tender
All Stages
Tender

Procurement Classification

Notice Type
Tender Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Open
Procurement Method Details
Open procedure (below threshold)
Tender Suitability
SME, VCSE
Awardee Scale
Not specified

Common Procurement Vocabulary (CPV)

CPV Divisions

50 - Repair and maintenance services

72 - IT services: consulting, software development, Internet and support

CPV Codes

50420000 - Repair and maintenance services of medical and surgical equipment

72225000 - System quality assurance assessment and review services

Notice Value(s)

Tender Value
£110,000 £100K-£500K
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
10 Oct 20241 years ago
Submission Deadline
24 Oct 2024Expired
Future Notice Date
Not specified
Award Date
Not specified
Contract Period
24 Oct 2024 - 28 Nov 2025 1-2 years
Recurrence
Not specified

Notice Status

Tender Status
Active
Lots Status
Not Specified
Awards Status
Not Specified
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
NHS ENGLAND
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
LEEDS
Postcode
LS1 4AP
Post Town
Leeds
Country
England
Major Region (ITL 1)
TLE Yorkshire and The Humber
Basic Region (ITL 2)
TLE4 West Yorkshire
Small Region (ITL 3)
TLE42 Leeds
Delivery Location
TLC North East (England), TLD North West (England), TLF East Midlands (England), TLG West Midlands (England), TLH East (England), TLJ South East (England), TLK South West (England)
Local Authority
Leeds
Electoral Ward
Hunslet & Riverside
Westminster Constituency
Leeds South

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts. 

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