BoA_Regulation_Medical_Devices_AI

Statement on The Impact of the "Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices" on the Evaluation of Tests Based on Measurement Theory

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.

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Also on the EFPA news magazine

Read more on the EFPA news magazine - Edition March 2023 : here.