Update information
October 2025: This manual has been updated to remove information in section 8 about guidance surveillance and instead refer to the processes and methods guide for NICE-wide guidance surveillance.
July 2025: This manual has been updated to align with the NICE HealthTech programme manual, which covers the methods and processes that NICE follows when evaluating health technology products (such as diagnostics, medical devices, digital technologies) and interventional procedures, when guidance produced is not technology appraisal or highly specialised technologies guidance.
For medtech and diagnostics guidance that started development before 14 July 2025, the previous version of the manual applies.
May 2025: This manual was updated to include guidance on the evidence and impact of health inequalities and how this affects decision making. For more information on this modular update, please see the support document published alongside the updated manual.
October 2023: This manual was updated to include guidance on the cost-comparison process, streamlined decision making and operating efficiently. For further information on this modular update please see the accompanying report published alongside the updated manual.
Minor changes since publication
June 2025: Sections 5.10.4, 5.10.5, 5.10.6 and 5.10.22 were updated to note that the threshold for the budget impact test has now increased from £20 million to £40 million.
December 2024: In the section on types of recommendation, minor updates were made to the terminology now used by a committee when making a recommendation.
ISBN: 978-1-4731-7284-5