Medical Device Regulatory Compliance

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 '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