Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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IMDRF codes – medical device problem Level 1 codes

• Infusion or Flow Problem • Activation, Positioning or Separation Problem • Protective Measures Problem • Compatibility Problem • Contamination /Decontamination Problem • Environmental Compatibility Problem • Installation-Related Problem • Labelling, Instructions for Use or Training Problem • Human-Device Interface Problem • Use of Device Problem • Adverse Event Without Identified Device or Use Problem • No Apparent Adverse Event • Insufficient Information • Appropriate Term/Code Not Available

• Patient Device Interaction Problem • Manufacturing, Packaging or Shipping Problem • Chemical Problem • Material Integrity Problem • Mechanical Problem • Optical Problem • Electrical /Electronic Property Problem • Calibration Problem • Output Problem • Temperature Problem • Computer Software Problem • Connection Problem • Communication or Transmission Problem

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