OBJECTIVES: To review submissions to the Medical Technologies Evaluation Programme (MTEP) of NICE over the past 2 years to assess the proportion of devices receiving positive recommendations and to identify the key factors leading to a negative recommendation.

METHODS: The NICE database was searched for published medical technologies guidance from June 2021 to June 2023 (searches conducted 23^rd June 2023). We interrogated the submissions and extracted key information including device name and characteristics, indication, recommendation, and key criticisms from the NICE committee meeting.

RESULTS: 26 MTEP guidance documents were published over the 2-year period; 17 were new guidance documents and 9 were guidance documents that had been updated following a review process. 2 submissions were for digital apps, 7 submissions focused on devices for identification or prevention of disease, and the remaining 17 focused on devices to treat a condition or aid a procedure.

Of the 26 MTEP decisions, 13 devices were recommended in full (50%), 5 were recommended in patient subgroups or recommended with a requirement for ongoing research (19%) and 8 were not recommended (31%). Lack of good quality evidence was cited as the main reason for a negative recommendation as the patient and healthcare benefits were uncertain and could not be proven. Additional trials or the collection of real-world evidence was recommended by NICE in these situations. For the 9 devices where guidance was updated, 1 device was not recommended, 1 device was recommended in a subgroup, and 7 devices were fully recommended.

CONCLUSIONS: To increase the chances of positive recommendation following MTEP, medical device manufacturers need to carefully consider the level of evidence available for their device ahead of submission. An evidence review and gap analysis, which can be facilitated via the Medtech Early Assessment tool (META), is recommended.