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SRPS CEN/TR 12401:2025

Dentistry - Guidance on the classification of dental devices and accessories

Jul 31, 2025

General information

60.60     Jul 31, 2025

ISS

Z106

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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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WITHDRAWN
SRPS CEN/TR 12401:2011

NOW

PUBLISHED
SRPS CEN/TR 12401:2025
60.60 Standard published
Jul 31, 2025

Related project

Adopted from CEN/TR 12401:2025 IDENTICAL