DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILon in vitro diagnostic medical devices
This Directive shall apply to in vitro diagnostic medical devices and their accessories. For the purposes of this Directive
不限 2024 2023 2022 2021 2020 2019 2018 2017 2016 2015 2014 2013 2012 2011 2010 2009 2008 2007 2006
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.
medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination,
The document herein was produced by the International Medical Device Regulators Forum (IMDRF),
This document is inscribed in the framework of the International Medical Device Regulators Forum (IMDRF).
This document was produced by the International Medical Device Regulators Forum.
Title: Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations
on in vitro diagnostic medical devices