EU MDR 2017/745

  • Replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC)
  • 3 year transition period in effect until May 2021 for manufacturers who currently sell CE marked devices
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ISO 13485:2016

  • ISO 13485 is a voluntary quality system standard
  • Generic in nature
  • Management is held accountable for the quality management system
  • Appropriate for medical device manufacturers, contract manufacturers, component manufacturers, service
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