Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and advisor to MedTech suppliers reports on a new consultation from medicines and medical device assessor, NICE.
The National Institute for Health and Care Excellence (NICE) has launched a public consultation on proposed updates to its PMG36 manual.
The proposed changes are designed to support the production of technology appraisals on HealthTech – medical devices, diagnostics and digital technologies – as set out in the NHS 10-Year Plan. Importantly, the updates will not affect how medicines are assessed.
While the existing PMG36 manual can be applied to HealthTech, it has historically been used predominantly for medicines. The revised manual will provide processes and methods better tailored to the unique characteristics of the HealthTech landscape.
The consultation is open until 5pm on 22 October 2025, and can be accessed here: NICE consultation on PMG36 updates. The MedTech sector should engage with the consultation.
This consultation is significant as it represents a step towards ensuring that the UK’s health system can properly evaluate and adopt innovative technologies at pace. For developers and providers, the changes could mean clearer pathways for bringing new solutions to market and greater confidence in how evidence will be assessed.
The Author used AI in preparing this article, comments upon, or questions about which can be addressed to chris.whitehouse@whitehousecomms.com.
