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CEN/TR 12401:2025

Dentistry - Guidance on the classification of dental devices and accessories CEN/TR 12401:2025

Publication date:   Jun 16, 2025

General information

60.60   Standard published   Apr 16, 2025

CEN

CEN/TC 55 Dentistry

Technical Report

11.060.01   Dentistry in general

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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 legislation

Legislation 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

Legislation 2017/745

Life cycle

PREVIOUSLY

WITHDRAWN
CEN/TR 12401:2009

NOW

PUBLISHED
CEN/TR 12401:2025
60.60 Standard published
Apr 16, 2025




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