IVD medical device definition

IVD medical device means a medical device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.
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Examples of IVD medical device in a sentence

  • SPECIMEN RECEPTACLE: An IVD medical device, whether vacuum-type or not, specifically intended by their product owner for the primary containment of specimens derived from the human body.

  • This may not apply to certain IVD medical device if the activity of the virus and other transmissible agent are integral to the intended purpose of the IVD medical device or when such elimination or inactivation process would compromise the performance of the IVD medical device.

  • Under the terms of such subcontracting relationship (the “Biomarker Agreement”), OV shall retain worldwide commercialization rights to the DRP Biomarker in the Field, including but not limited to use of the DRP Biomarker as an In Vitro Diagnostic (IVD) medical device and/or as a Laboratory Developed Test (LDT) diagnostic.

  • The IVD medical device regulatory framework being implemented between 1 July 2010 and 30 June 2017 is designed to ensure all IVD medical devices, including in-house IVD medical devices, undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use.

  • This may not apply to certain e virus and IVD medical device if the activity of th other transmissible agent are integral to the intended purpose of the IVD medical device or when such elimination or inactivation process would compromise the performance of the IVD medical device.

  • This change is a subject of an obligation to apply at medicines competent authority SÚKL for additional scientific opinion confirming the that the quality and safety of the substance are maintained For IVD devices: To inform ITC about changes to the pathogen and markers of infections to be tested, including ability of such changes to affect the performance of IVD medical device concerned.

Related to IVD medical device

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Consumables and medical devices means (consumables) items that require regular replacement (e.g. batteries) to keep a medical device (such as a hearing aid) operational. Many medical devices require consumables.

  • Medical cannabis pharmacy means the same as that term is defined in Section 26-61a-102.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.