European Parliament and Council (2017)
Official Journal of the European Union.
URL: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
Abstract. The EU Medical Device Regulation that superseded the 1993 MDD — establishing stricter usability and post-market surveillance requirements, including mandatory IEC 62366 conformity for medical-device user-interface design. Came into force 2021.
Tags: healthcare regulatory eu medical-devices