Update information
October 2025: This manual has been updated to include approaches for developing guidance for HealthTech products already in existing use within the NHS. This replaces the late-stage assessment interim process and methods statement.
For medtech and diagnostics guidance that started development before 14 July 2025, the pre-July 2025 version of the NICE health technology evaluations manual (PMG36) applies.
For early-use guidance that started development before 14 July 2025, the NICE early value assessment interim statement applies.
For existing-use guidance that started development before 23 October 2025, the NICE LSA interim process and methods statement applies.
ISBN: 978-1-4731-7287-6