ntr298-C_2022247EN.01000101-E0299
(298) For medical devices and in vitro diagnostic medical devices, Regulation 2017/745 and Regulation 2017/746 outline the procedure for dealing with devices presenting an unacceptable risk and other non-compliances. The process is facilitated by means of the electronic system Eudamed. See Articles 95 to 97 of Regulation 2017/745.
Source: EUR-Lex (Cellar) · retrieved 2026-09-25 · Text as adopted (Official Journal); later amendments are not incorporated in this text.