This document provides guidance 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.
Directives 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
PUBLISHED
SRPS CEN/TR 12401:2011
PROJECT
dnaSRPS CEN/TR 12401:2023
50.20
Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Dec 5, 2024
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