Medical Device Directives definition

Medical Device Directives means the 3 following directives:
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Medical Device Directives has the meaning set forth in the definition of Healthcare Laws.
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Examples of Medical Device Directives in a sentence

  • ArthroCare will manufacture Licensed Products in accordance with ISO 9000 Standards, EN 46000 Standards, FDA Quality Systems Regulations (including Current Good Manufacturing Practices), and requirements of the Medical Device Directives ("MDD") and the then-current product specifications, as may be modified from time to time by the mutual written consent of the parties hereto.

  • Bovie shall also comply with the essential requirements of the European health, safety and environmental protections legislations set forth in the European Union Council Medical Device Directives (the "EU Medical Device Directives") and declare such compliance by affixing the "CE Marking" to the Products shipped to Arthrex.

  • Such quality plans, which may be amended by the parties from time to time, shall be consistent with the requirements of the Quality System Regulations and European Medical Device Directives, and shall be of a form and complexity consistent with customary industry standards.

  • The premises and equipment used to manufacture the Product shall be maintained according to the standards outlined in ISO 13485:2003 (Quality Management Standard for Medical Devices), ISO 14971 (Risk Management System), Annex I Essential Requirements of the Medical Device Directives 93/42/EEC and Sub-Chapter H, Part 820 of Title 21 of the United States Code of Federal Regulations (Quality Systems Regulations for Medical Devices), in each case, as may be amended from time to time.

  • COMPLAINTS / PRODUCT EVALUATION / NONCONFORMANCES SJM will file all reports it determines are required by FDA's Medical Device Reporting (MDR), Medical Device Directive's Vigilance Reporting regulations, and any other reports required by applicable regulating agencies.

  • For avoidance of doubt, and without limiting the generality of the foregoing, each Party shall be responsible for costs and expenses incurred by such Party in order to maintain quality systems and applicable certifications in compliance with United States quality systems regulations, Medical Device Directives (“MDD”), AATB and ISO 13485.

  • The Company is complying in all material respects with all applicable regulatory post-market reporting obligations, including, without limitation, adverse event reporting requirements set forth by the EU Medical Device Directives, as applicable, and, to the extent applicable, their national implementing laws in the European Union member states.

  • Establish its own manufacturing facility (or outsource to a third party) for the manufacture of the Products according to all regulatory requirements of the Territory in which the Products will be distributed (i.e., U.S. FDA Quality System Regulations, European Medical Device Directives, or Canadian Medical Device Requirements (CMDCAS)) utilizing the documents provided by CystoMedix pursuant to Section 3(c) below.

  • FDA; and (b) Medical Device Directives (“MDD”) regulated by the European Competent Authority; and (c) Health Canada Medical Device Regulations.

  • SUPPLIER will also sign the attached Agreement of Compliance with Medical Device Directives.

Related to Medical Device Directives

  • 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:

  • Advance health care directive means a power of attorney for health care or a record signed by a prospective donor containing the prospective donor's direction concerning a health care decision for the prospective donor.

  • 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:

  • 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.

  • Medical direction means direction, advice, or orders provided by a medical director, supervising physician, or physician designee (in accordance with written parameters and protocols) to emergency medical care personnel.