IVDR Scenarios

• Scenario 2 – Using CE-IVDs outside their intended scope
  Many labs adapt CE-marked IVDs by changing sample types, patient groups, or workflows. The moment you step beyond the manufacturer’s claimed scope, you are already in IH-IVD territory.

• Scenario 3 – Using non-CE products (e.g. RUO)
  If your lab relies on RUO kits, panels, or staining procedures for diagnostic use, these automatically turn to IH-IVDs. What seems like routine practice is in fact covered by IVDR Art. 5.5.

• Scenario 4 – Combining CE and non-CE devices
  Mixing CE-IVD components with academic tools, open-source software, or research-use products creates a hybrid system within a workflow. Such combinations are no longer “standard CE-IVD use” and fall into the IH-IVD category.

• Scenario 5 – Designing and developing your own solutions
  Whether assembling your own bioinformatics pipeline or building a testing algorithm in Excel, labs actively developing methods are manufacturing IH-IVDs. This is the clearest IH-IVD case - but also the one many labs underestimate in its regulatory impact.

What does it mean? InHouse means the lab becomes the “defacto” manufacturer of such devices; takes over the responsibility and has to fulfill the requirements of IVDR art 5.5, GSPR, and others.

• Scenario 1 – Using CE-IVDs strictly as intended (NOT In-House)

  If a lab uses only CE-marked devices exactly as claimed by the manufacturer - without modification or deviation - this is not considered an In-House IVD, and IVDR art 5.5 does not come to application.

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