--- title: "Medical Device Regulatory Compliance" ocid: "ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09" markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09.md" json_url: "https://d3tenders.com/contract/ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09.json" source: "Contracts Finder" current_stage: "Tender" buyer: "NHS ENGLAND" published: "2024-10-10" --- # Medical Device Regulatory Compliance Buyer: NHS ENGLAND Current stage: Tender OCID: ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09) [Download OCDS JSON](https://d3tenders.com/contract/ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09.json) ## Summary 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. ## Notice 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 ## Key Details | Field | Value | | --- | --- | | Publication source | Contracts Finder | | Latest notice | https://www.contractsfinder.service.gov.uk/Notice/be6f5aa4-37ba-4778-9da0-70b951797890 | | 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 | | All stages | Tender | ## Dates | Field | Value | | --- | --- | | Publication date | 10 Oct 2024 | | Submission deadline | 24 Oct 2024 | | Future notice date | Not specified | | Award date | Not specified | | Contract period | 24 Oct 2024 - 28 Nov 2025 | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | £110,000 | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Active | | Lots status | Not specified | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | NHS ENGLAND | | Locality | LEEDS | | Post town | Leeds | | Postcode | LS1 4AP | | Country | England | | ITL 1 | TLE Yorkshire and The Humber | | ITL 2 | TLE4 West Yorkshire | | ITL 3 | TLE42 Leeds | | Local authority | Leeds | | Electoral ward | Hunslet & Riverside | | Westminster constituency | Leeds South | | 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) | ## CPV Codes ### Divisions - 50 - Repair and maintenance services - 72 - IT services: consulting, software development, Internet and support ### Codes - 50420000 - Repair and maintenance services of medical and surgical equipment - 72225000 - System quality assurance assessment and review services ## Release History - 10 Oct 2024 at 15:17 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/be6f5aa4-37ba-4778-9da0-70b951797890 ## Documents - https://www.contractsfinder.service.gov.uk/Notice/be6f5aa4-37ba-4778-9da0-70b951797890 10th October 2024 - Opportunity notice on Contracts Finder ## Notice URLs - https://health-family.force.com/login - https://health-family.force.com/s/Welcome ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-c212a659-8acf-4ac9-ad6b-a5e936326c09.json.