OBJECTIVES: Health technology assessment (HTA) for medical devices is increasingly prioritised by decision-makers internationally. The UK’s National Institute for Health and Care Excellence (NICE) was one of the first HTA bodies to create a Medical Technologies Evaluation Programme (MTEP), in 2009/10. By recognising the methodological and industry challenges for device evaluation, MTEP aims to (1) simplify access to evaluation, (2) speed up the process and (3) increase evaluative capacity within NICE. In this study we assess the success of MTEP against these aims over its first four years. METHODS: We outline the challenges to industry and evaluators by presenting key market statistics for device innovation and contrasting these with pharmaceuticals. By considering the 18 medical technology guidance (MTGs) published to date (July 2010 – June 2014), we assess these according to stated NICE objectives, characteristics of industry, and device evaluation by NICE pre-MTEP. RESULTS: Whilst MTEP has lowered evidence requirements to improve accessibility, the programme continues to attract a subset of manufacturers: large firms (employing>250 people) represent just 1% of UK device companies but 37% of MTG company sponsors. The total target time for selection and assessment is 12 months—similar to NICE pharmaceutical appraisals—which is almost two-thirds of the average device lifetime; more than half MTGs exceeded this target (average: 16.5 months). MTG production has been lower than anticipated. CONCLUSIONS: The unique challenges of device HTA for decision-makers and industry provide strong justification for an evaluation system specific to medical devices. Whilst MTEP provides an accessible route to evaluation, barriers persist. The risk of guidance becoming out-dated quickly is significant. By choosing a cost-consequence approach to assessment, NICE may be neglecting to evaluate new (non-diagnostic) devices that benefit patients but are not cost-saving. To promote industry submission to MTEP, a clear link must be established between guidance and uptake.