Mastering the art of the state of the art (under EU MDR 2017/745)

Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical Device Regulation (EU MDR) 2017/745. In this article, I share my experience of working on SOTA documents over the last four years. It first briefly recapitulates the SOTA requirements of the EU MDR (that are in fact almost non-existent) followed by the different steps required to conduct and document the literature search. Also included are some tips and tricks on structuring the SOTA. Finally, advantages and limitations of different scientific literature databases are provided.