Source: https://tendernation.io/opportunities/01a13cf1-96d9-71ce-9f77-7bedb52647ae/medical-device-regulatory-compliance closed GB open procedure Suitable for SMEs # Medical Device Regulatory Compliance [NHS England](https://tendernation.io/buyers/nhs-england) Estimated value £110,000 Published 10 Oct 2024 Deadline Closed 24 Oct 2024 ## Who can bid - Buyer says suitable for SMEs The buyer ticked “suitable for SMEs” on the notice. Anyone can still bid. - Buyer says suitable for VCSEs The buyer ticked “suitable for voluntary, community and social enterprises” on the notice. - Small contract value Valued under £135,018 including VAT, the lowest Procurement Act threshold for goods and services. - Open procedure Anyone can submit a full tender; there is no shortlisting stage. [More contracts for small businesses and VCSEs](https://tendernation.io/opportunities/for-small-businesses) ## About this tender 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: [health-family.force.com/login](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 [health-family.force.com/s/Welcome](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: Read full description ## CPV classification Repair and maintenance services of medical and surgical equipment Source Contracts Finder (UK) [View official notice](https://www.contractsfinder.service.gov.uk/notice/c212a659-8acf-4ac9-ad6b-a5e936326c09) Never miss a tender like this again Get AI summaries, deadline alerts and a bid pipeline for tenders matched to your business. Free to start. 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