Medical device regulatory compliance

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