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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IVD medical device means a 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. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles
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Examples of IVD medical device in a sentence

  • This may not apply to certain IVD medical devices 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.

  • In vitro diagnostics (IVD) medical device The CE marking is the manufacturer's declaration that the medical product meets the requirements of the applicable EC directives and regulations.

  • An IVD medical device has the medical device classification applying under the classification rules set out in Schedule 2A.

  • The hTERT test is registered as an IVD medical device in the US (Class 1 IVD), Europe (CE-IVD marking), Australia (Class I IVD) and South Korea (Class II IVD) for use as a clinical diagnostic by pathology laboratories for the detection of hTERT in cytopathology samples.

  • IVD medical device post market surveillance.‌Manufacturers have a responsibility to implement an effective post-market surveillance system to ensure that any problems or risks associated with the use of their device once freely marketed are identified early, reported to competent authorities, and acted upon.

  • In particular, where appropriate, the design should address sensitivity, specificity, accuracy which is trueness and precision (repeatability and reproducibility), control of known relevant interference and limits of detection.These performance characteristics need to be maintained during the lifetime of the IVD medical device as indicated by the manufacturer.

  • A medical device, other than an IVD medical device, has the medical device classification applying under the classification rules set out in Schedule 2.

  • A rationale that, for an indefinite period, the storage conditions could not affect IVD medical device safety or performance.

  • To govern the process of demonstrating compliance, the Regulations require manufacturers to establish, implement, document and maintain a medical device quality management system e.g. BS EN ISO 13485:201689 to ensure the ongoing quality, safety and performance of their medical device or IVD medical device.

  • Risk control measures adopted by manufacturers for the design and manufacture of the medical device and IVD medical device should conform to safety principles, taking account of the generally acknowledged state of the art.

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.

  • Cephalometric device means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

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

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

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

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Pharmaceutical care means the provision of drug therapy and

  • Licensed health care provider means a physician, physician assistant, chiropractor, advanced registered nurse practitioner, nurse, physical therapist, or athletic trainer licensed by a board.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • HITECH means the Health Information Technology for Economic and Clinical Health Act.

  • Health Canada means the department of the Canadian Government known as Health Canada and includes, among other relevant branches, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate;

  • Rural health clinic means a rural health clinic as defined under section 1861 of part C of title XVIII of the social security act, chapter 531, 49 Stat. 620, 42 U.S.C. 1395x, and certified to participate in medicaid and medicare.

  • Radiologic technologist means an individual, other than a licensed doctor of medicine, osteopathy,

  • Orthotic device means a custom-fitted or custom-fabricated medical device that is applied to a part of the human body to correct a deformity, improve function, or relieve symptoms of a disease.

  • Medical marijuana means marijuana that is grown, processed, dispensed, tested, possessed, or used for a medical purpose.

  • Nuclear medicine technologist means an individual who holds a current certification with the American Registry of Radiological Technologists or the Nuclear Medicine Technology Certification Board.

  • Licensed health care professional means a person who possesses a professional medical license that is valid in Oregon. Examples include, but are not limited to, a registered nurse (RN), nurse practitioner (NP), licensed practical nurse (LPN), medical doctor (MD), osteopathic physician (DO), respiratory therapist (RT), physical therapist (PT), physician assistant (PA), or occupational therapist (OT).

  • Therapeutic school means a residential group living facility:

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Radiopharmaceutical service means, but is not limited to, the procurement, storage, handling preparation, labeling, quality assurance testing, dispensing, delivery, recordkeeping, and disposal of radiopharmaceuticals and other drugs.

  • Federal Health Care Program means any “federal health care program” as defined in 42 U.S.C. § 1320a-7b(f), including Medicare, state Medicaid programs, state CHIP programs, the Veterans Administration, TRICARE and similar or successor programs with or for the benefit of any Governmental Authority, and in each case any third party payor administering such programs.