Application of the Medical Device Directive to Software: Methodological Challenges

The European Union (EU) adopted the revised Medical Device Directive (MDD) in 2010. A major change is that software for certain purposes is now considered a medical device (MD) and thus is subject to the same regulation as MDs. That means the integration of a usability engineering process with its documentation in a usability file is now mandatory. This paper presents a case study, performed in particular conditions, to (i) illustrate the adopted user-centered approach to be compliant with the ergonomic-essential requirement and (ii) discuss the methodological challenges associated even under such favorable conditions. The results raise the question about whether software regulation is feasible. We conclude that there is a need to think about recommendations for how regulation could be implemented with support for manufacturers, with minimal impact on innovation, and with rigorous but not too rigid evaluation procedures.