Medical device regulatory compliance
Details
- Buyer
- NHS England
- Published
- 17 October 2024
- Submission
- 24 October 2024
- Source
- uk:atamis:dhsc
Tender description
There are currently 5 Software medical devices (SaMD) products registered with the MHRA with NHS-E 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 NHS-E 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
Timeline
- Completed: Tender published17 October 2024Current notice
- Completed: Submission date24 October 2024
About the buyer
NHS England runs the NHS in England, and buys as a central healthcare organisation with its own team of procurement professionals. Much of this procurement flows through framework agreements and the Crown Commercial Service. Seven regional teams support the commissioning of healthcare services across the country. The central commercial function that develops procurement strategy for the whole NHS sits here.
Clinical services are commissioned directly or through the Provider Selection Regime.
Over the past 5 years, most of NHS England's contract awards have been in education and training, health and social work, and IT services.
Decision makers
Connect with the people behind this procurement.
| Contact name | Job title | Phone number | Work email |
|---|---|---|---|
| Head of Procurement | +44 •••• •••••• | ••••••••@nhs-england.gov | |
| Commercial Director | +44 •••• •••••• | ••••••••@nhs-england.gov | |
| Procurement Manager | +44 •••• •••••• | ••••••••@nhs-england.gov | |
| Category Lead | +44 •••• •••••• | ••••••••@nhs-england.gov | |
| Senior Buyer | +44 •••• •••••• | ••••••••@nhs-england.gov | |
| Contracts Manager | +44 •••• •••••• | ••••••••@nhs-england.gov |
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