Medical Device Report definition

Medical Device Report or “MDR” means a report filed with FDA to communicate an event when Seller or Buyer becomes aware (as such phrase is defined in 21 CFR 803.3(c)) of information that reasonably suggests that one of its marketed Products:
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Medical Device Report means all reports required to be submitted to FDA consistent with 21 CFR Part 803. “Merger Consideration Spreadsheet” has the meaning set forth in Section 5.1(b).
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Medical Device Report means all reports required to be submitted to FDA consistent with 21 CFR Part 803.
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Examples of Medical Device Report in a sentence

  • Each of the parties agrees to notify the other within five Business Days of receipt from any customer of any significant medical injury or Medical Device Report (“MDR”) fileable complaint relating to any of the Products.

  • ATS and GBI agree to notify the other within two (2) business days of receipt from any customer of any complaint or Medical Device Report ("MDR") filable complaint relating to the Product.

  • The parties shall consult with each other prior to the submission of any Medical Device Report and unless restricted by applicable law, each party shall use its reasonable efforts to provide the other with a copy of each Medical Device Report related to the CLAVE Product to be submitted by a party to the FDA at least two business days prior to the submission.

  • Each party will immediately (within two business days) notify the other party in writing of any event or complaint that gives rise or could give rise to the need to file a Medical Device Report (hereinafter, an "MDR") within the meaning of the Federal Food, Drug and Cosmetic Act, as amended (the "Act"), with respect to any Product or the manufacture, distribution or use thereof in accordance with the MDR regulation, 21 C.F.R. Part 803.

  • CL and HJL agree to notify the other within two (2) business days of receipt from any customer of any complaint or fileable Medical Device Report (“MDR”) relating to the Product.

  • If the Supplier files a Medical Device Report for the product, or any similar product, the Supplier provides to the Customer, the Supplier shall promptly notify the Customer.

  • If a party is presented with a possible Medical Device Report (“MDR”) event involving the provision of or failure to provide a component of a Hybrid Kit, the party originating the applicable product shall bear the responsibility for evaluation and, if necessary, submission of all information required under the applicable MDR Regulation, as set forth in 21 C.F.R. Part 803.

  • Each device failure/adverse event will be assessed for possible reporting as a Medical Device Report (MDR), and a determination will be made in accordance with the Sponsor’s standard operating procedure.

  • The FDA Medical Device Report (MDR) system includes reports of bougies rupturing and leaving mercury inside the patient as well as in the room.

  • Each of the parties agrees to notify the other within three (3) Business Days of receipt of any significant complaint or information relating to the safety or effectiveness of any Hxxxxx Products or Fully Integrated EnSite System or otherwise relating to an event that could trigger a need to file a Medical Device Report (“MDR”).

Related to Medical Device Report

  • 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:

  • Peer-reviewed medical literature means a scientific study published only after having been critically

  • 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.

  • 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.

  • 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.

  • 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 evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • 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;

  • Forensic analysis means the practice of gathering, retaining, and analyzing computer-related data for investigative purposes in a manner that maintains the integrity of the data.

  • Licensed behavior analyst means a person who holds current certification or meets the standards to be certified as a board certified Behavior Analyst or a board certified Assistant Behavior Analyst issued by the Behavior Analyst Certification Board, Inc., or any successor in interest to that organization and whom the Board of Psychological Examiners licenses as a Behavior Analyst.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • 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.

  • Drug test means a test designed to detect the illegal use of a controlled substance.

  • Alcohol Screening Device (ASD) means a breath or saliva device, other than an Evidential Breath Testing Device (EBT), that is approved by the National Highway Traffic Safety Administration and placed on its Conforming Products List for such devices.

  • Credential analysis means a process or service by which a third party affirms the validity of an identity document described in section 25(6)(c) through a review of public and proprietary data sources conducted remotely.

  • 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.

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

  • Marketing Materials has the meaning ascribed thereto in NI 41-101;

  • Diagnostic source assembly means the tube housing assembly with a beam-limiting device attached.

  • 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.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • COVID-19 test means a viral test for SARS-CoV-2 that is:

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).