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DS CEN/TR 12401:2025

Dentistry - Guidance on the classification of dental devices and accessories

Jun 24, 2026

General information

60.60     Jun 24, 2026

95.99   

DPS

DPS/KT 55

Technical Report

11.060.01  

English  

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Scope

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.

Related directives

Directives related to this standards.

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

WITHDRAWN
DS CEN/TR 12401:2009

NOW

PUBLISHED
DS CEN/TR 12401:2025
60.60 Standard published
Jun 24, 2026

Related project

Adopted from CEN/TR 12401:2025 IDENTICAL