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a voluntary group of global medical device regulators from around the world. The document has been subject to consultation throughout its development.

It replaces the "Guidance on a Unique Device Identification (UDI) System for Medical Devices" adopted by the Global Harmonization Task Force (GHTF) on 16 September 2011.

The document herein was produced by the International Medical Device Regulators Forum (IMDRF), a voluntary group of medical device regulators from around the world. The document has been subject to consultation throughout its development.

This document was produced by the International Medical Device Regulators Forum. There are no restrictions on the reproduction or use of this document; however, incorporation of this document, in part or in whole, into another document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the International Medical Device Regulators Forum.

This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive

medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination,

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

This Regulation does not seek to harmonise rules relating to the further making available on the market of medical devices after they have already been put into service such as in the context of second-hand sales.