Psychologists would think it absurd to classify same psychological instrument once as a medical device (computer-based procedure) and once not (“manual” procedure). However under Regulation (EU) 217/145 this could happen by organisations and government bodies not well versed in the existing test quality standards. This one of many issues behind the statement by the EFPA Board of Assessment to this regulation.
The EFPA statement is aimed in particular at providers and users of psychometric tests, as well as organisations and government bodies that are entrusted with the classification of procedures as medical devices in the context of the implementation of Regulation (EU) 2017/745. From the information provided and our analysis, we conclude that psychometric tests (whether in hard copy or software enabled) are not medical devices.