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dnaSRPS CEN/TR 12401:2023

Dentistry - Guidance on the classification of dental devices and accessories

General information

50.20     Dec 5, 2024

50.60    Feb 27, 2025

ISS

Z106

Technical Report

11.060.01  

English  

Scope

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.

Related directives

Directives related to this standard.

2017/745

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

Life cycle

PREVIOUSLY

PUBLISHED
SRPS CEN/TR 12401:2011

NOW

PROJECT
dnaSRPS CEN/TR 12401:2023
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Dec 5, 2024

Related project

Adopted from FprCEN/TR 12401 IDENTICAL

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