Hill Dickinson and Medilink North of England have collaborated with the University of Liverpool’s Civic Health Innovation Zone (CHI-Zone) to produce a report on the legal and regulatory framework for medical devices, including software / AI as a medical device.
The report has been produced to support innovators working in medical device development. It outlines the regulatory framework under the Medical Devices Regulations 2002 and the oversight of the Medicines and Healthcare products Regulatory Agency (MHRA) including classification, routes to market and post market surveillance.
The report also addresses emerging areas such as software, including AI, as a medical device, and maps complementary frameworks such as NHS DTAC requirements, NICE evidence standards and data protection, explaining how these operate in practice within NHS and social care settings.
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