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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
天之恒依托醫(yī)療器械注冊認證、臨床研究經驗豐富的全球服務團隊，為醫(yī)療器械（含IVD等）企業(yè)提供產品注冊認證、大動物試驗、臨床試驗及孵化轉化等全球市場合規(guī)準入的全流程服務。
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