OBJECTIVES : The learning curve impacts assessment of effectiveness, safety and costs associated with the use of medical devices /MDs/ being a barrier to the conduct of randomized controlled trials /RCTs/.

The objective of this study is to review and collect actual data to which extent this is perceived as contextual factor into health technology assessment /HTA/ of MDs.

METHODS : An exploratory literature review was conducted only for articles published in English for the period January 2013 – May 2019.

RESULTS : 24 articles were classified as eligible; 2 were excluded as non- specific, 1 was removed due to duplication. Only 5 from 21 articles /24%/ identified the learning curve as a specific barrier to the conduct of RCT with MDs. In all articles learning curve appears as part of the problem, along with designing RCTs for MDs, product lifecycle, value- based procurement and the potential of real- world evidence data.

CONCLUSIONS : Changes in performance caused by learning has been recognized to present particular difficulties in HTA as early as in 2001. The limited number of recent articles exploring the problem can be explained by the fact that learning curve remains not appropriately incorporated, if at all, in HTA for MDs. None article accurately reflects the unique role of learning curve as a specific for MDs barrier in the conduct of RCTs, thus creating a serious pitfall for HTA with MDs.