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장치에 대한 임상 평가 센터

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Frequently Asked Questions

임상 평가

  • Is Clinical Evaluation Report mandatory?
    According to Chapter VI annex 61 of EU MDR Regulation 2017/745, submission of Clinical Evaluation Report (CER) is mandatory. CER has to be submitted in order to demonstrate the performance and safety of the corresponding medical device.
  • What data is considered as Clinical Data?
    Clinical Data means information concerning safety or performance that is generated from the use of a device and is sourced from the following: Clinical investigation(s) of the device concerned Clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated Reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated Clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up
  • What is CE Marking?
    ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.
  • What is Clinical Evidence?
    ‘Clinical Evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer.
  • What is Implantable Device?
    ‘Implantable device’ means any device, including those that are partially or wholly absorbed, which is intended: to be totally introduced into the human body to replace an epithelial surface or the surface of the eye by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.



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