Content for Instructions for Use (IFU) checklist for IVDR 2017/746 – In-vitro Diagnostics


The In-Vitro Diagnostics Medical Device Regulation IVDR 2017/746, Annex I, 20.4, defines the content requirements for Instructions for Use (IFU) for in-vitro diagnostics (IVDs). The information to be supplied in the IFU is crucial for the communication of safety, performance and correct use to the user. Find here the checklist for the IFU content, delivered as:

  • Word file format
  • Compliant to the requirements per IVDR 2017/746
  • Supportive information


The IVDR 2017/746 defines in its Annex I, 20.4 the content requirements for the information in the Instructions for Use (IFU) for in-vitro diagnostics medical devices (IVDs). Find here the checklist and supportive information to correctly establish an IFU for IVDs.