Investigational Medical Device definition

Investigational Medical Device means the CE marked or non-CE marked study device(s) or control material(s) identified in the Clinical Investigation Plan.
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Investigational Medical Device means the CE marked or non-CE marked study device(s) or control material(s) identified in the Clinical Investigation Plan; Investigator Site means the activities conducted under this Agreement and overseen by one Principal Investigator; Investigator Site File means the file maintained by the Principal Investigator containing the documentation specified in EN ISO 14155:2020; Investigator Site Investigation Completion means the conclusion of all Clinical Investigation Plan required activities for all enrolled Clinical Investigation Participants at the Investigator Site; Know-How means all technical and other information that is not in the public domain (other than as a breach of confidence) including, but not limited to, information comprising or relating to concepts, discoveries, data, designs, formulae, ideas, inventions, the IMD, methods, models, procedures, designs for experiments and tests and results of experimentation and testing, processes, specifications and techniques, laboratory records, clinical data, manufacturing data and information contained in submissions to Regulatory Authorities, whether or not protected by Intellectual Property Rights or any applications for such rights; Lead Trial Site Where the Principal Investigator has oversight of Study activities at the Trial Site and at an Other Trial Site(s), the Trial Site is the Lead Trial Site, being the ‘hub’ in a ‘hub and spoke’ trial site delivery model; Material [Delete if 4.16.10, 4.16.11 and Appendix 6 are not required] means any clinical biological sample, or portion thereof, derived from Clinical Investigation Subjects, including information related to such material, analysed by the Trial Site or Other Trial Site in accordance with the Clinical Investigation Plan, or otherwise supplied under Appendix 6 to the Sponsor or its nominee; MHRA means the Medicines and Healthcare products Regulatory Agency; MIA means the Master Indemnity Agreement that may be applicable in the part of the United Kingdom where the Trial Site is constituted;
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Investigational Medical Device means a device, which is an object of a clinical investigation or research or development involving one or more subjects to determine the safety or effectiveness of a device;
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Examples of Investigational Medical Device in a sentence

  • The Trial Site shall ensure that neither administration of the Investigational Medical Device to any Participant nor any other clinical intervention arising from the Clinical Investigation Plan takes place in relation to any Participant until it is satisfied that all relevant approvals have been obtained.

  • Until the Sponsor has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply the Investigational Medical Device to the Trial Site, nor shall it authorise the Trial Site to use its own supply of Investigational Medical Devices for this Clinical Investigation.

  • If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in Clause 4.5 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, they may request the Health Research Authority (HRA) to authorise deferral of registration.

  • The Parties may only disclose Confidential Information to their own officers, Agents and employees (and in the case of the Sponsor, those of its Affiliates and, if applicable, other parties who may have contractual rights in the Results or to develop the Investigational Medical Device (for example, through a licence, collaborative agreement, Co-Promotion Agreement, Co-Development Agreement, etc.

  • The Sponsor shall ensure that the Results of the Clinical Investigation are published on a free, publicly accessible clinical study results database within one (1) year after the Investigational Medical Device is first approved and made commercially available in any country or, if the Clinical Investigation is a Non-Regulated Clinical Investigation, within one (1) year of Clinical Investigation Completion.

  • The provisions of this Clause 9.2 shall also apply to the Trial Site’s use of the name, trademark, service mark, and / or logo of any third parties collaborating with the Sponsor on the Clinical Investigation and / or the Investigational Medical Device (“Sponsor Collaborators”) provided that the Trial Site has been notified of the identity of the Sponsor Collaborators.


More Definitions of Investigational Medical Device

Investigational Medical Device means a device, which is an object 15
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Investigational Medical Device or “Test Medical Device” means medical device being assessed for safety or performance in a clinical investigation. ​
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Related to Investigational 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:

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

  • Background investigation means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

  • FDA means the United States Food and Drug Administration or any successor agency thereto.

  • 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.

  • 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.

  • investigating authority means an authority that in terms of national legislation may investigate unlawful activities;

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

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

  • 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.

  • Investigating Department means any department / division / office of SCI investigating into the conduct of the Entity and shall include the Vigilance Department, “Central Bureau of Investigation, the State Police or any other authority or entity set up by the Central or State Government having powers to investigate”.

  • 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.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • 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).

  • national regulatory authority means a national regulatory authority designated in accordance with Article 39(1) of Directive 2009/73/EC;

  • Investigation Committee means the Investigation Committee appointed by the Board under Regulation 5 of these Regulations;

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Chemical dependency professional means a person certified as a chemical dependency professional by the department of health under chapter 18.205 RCW.

  • Licensed mental health professional or "LMHP" means a physician, licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, licensed substance abuse treatment practitioner, licensed marriage and family therapist, certified psychiatric clinical nurse specialist, licensed behavior analyst, or licensed psychiatric/mental health nurse practitioner.