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 S ection 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

  • 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 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.

  • 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.

  • Valley Forge and CODMAN shall actively cooperate in investigating the circumstances underlying in the Medical Device Report and in responding to FDA inquiries.

  • 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 H▇▇▇▇▇ Products or Fully Integrated EnSite System or otherwise relating to an event that could trigger a need to file a Medical Device Report (“MDR”).

  • If party is presented with a possible Medical Device Report ("MDR") event involving the provision of or failure to provide a component of a Surgical or Instrument Express Program or a product in connection with the PCMS Services, 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.

  • 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.

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

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.