This document provides an opinion on the application of the classification rules in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices as they pertain to dental devices and accessories.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
WITHDRAWN
CEN/TR 12401:2009
PUBLISHED
CEN/TR 12401:2025
60.60
Standard published
Apr 16, 2025