CEN/TC 55/WG 3 - Classification
To consider the classification for medical devices used in dentistry with a view to maintaining the guidance document CR 1240.
Classification
To consider the classification for medical devices used in dentistry with a view to maintaining the guidance document CR 1240.
General Information
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.
- Technical report23 pagesEnglish languagee-Library read for1 day
This CEN Technical Report provides guidance on the application of the classification rules in Council Directive 93/42 EEC of 14 June 1993, amended by Directive 2007/47/EC, concerning medical devices as they pertain to dental devices and accessories.
- Technical report10 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
CEN/TC 55/WG 3 is a Working Group within the European Committee for Standardization (CEN). It is named "Classification" and is responsible for: To consider the classification for medical devices used in dentistry with a view to maintaining the guidance document CR 1240. This committee has published 2 standards.
CEN/TC 55/WG 3 develops CEN standards. The scope of work includes: To consider the classification for medical devices used in dentistry with a view to maintaining the guidance document CR 1240. Currently, there are 2 published standards from this working group.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.