Our Independent Healthcare team has partnered with Medilink North of England and the University of Liverpool’s Civic Health Innovation Zone (CHI-Zone) to produce a comprehensive new report mapping the legal and regulatory landscape for medical devices in the UK.
Designed to support innovators, developers and healthcare organisations, the report provides a detailed overview of the Medical Devices Regulations 2002 and the role of the Medicines and Healthcare products Regulatory Agency (MHRA). It explains key requirements including device classification, routes to market and post-market surveillance obligations.
Recognising the pace of technological change, the report also explores emerging areas such as software and artificial intelligence as medical devices.
Bringing together complementary frameworks – including NHS DTAC requirements, NICE evidence standards and data protection considerations – the practical guidance aims to help organisations navigate regulatory complexity and bring safe, effective innovations to market more efficiently.
For organisations looking to translate regulatory insight into practical action, our specialist Independent Healthcare team offers tailored legal and strategic support across the full lifecycle of medical devices and digital health solutions. Explore how our experts can support you.