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FprCEN/TR 12401

Dentistry - Guidance on the classification of dental devices and accessories FprCEN/TR 12401

Publication date:   Dec 5, 2024

General information

50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks   Dec 5, 2024

CEN

CEN/TC 55 Dentistry

Technical Report

11.060.01   Dentistry in general

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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 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

PUBLISHED
CEN/TR 12401:2009

NOW

IN_DEVELOPMENT
FprCEN/TR 12401
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Dec 5, 2024