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Create an MDR or IVDR case

Start a device case and provide the information needed for its first review.

Your case

Where to find it

My Cases → New case

You need

  • Access to your organisation's client workspace.
  • The device name, regulation and intended purpose.

Start with what you know

Enter the device name, choose MDR or IVDR, select the device class when you know it, and describe the intended purpose. Choose the unsure option instead of guessing a class.

The New case wizard with synthetic MDR device details, the Not sure yet risk-class choice, and an intended-purpose statement.
Start the case with the device facts you can state truthfully; use Not sure yet instead of guessing the risk class.
  1. Choose "New Case" in the sidebar, or "New case" at the top of My Cases (the wizard itself is headed "New case").
  2. Complete the device details. Treat the intended purpose as regulated content, not a marketing tagline.
  3. Add the source documents available now. You can provide further evidence from the case later.
  4. Review the information and create the case.
The New case wizard's Documents step with connected sources marked Available soon, a manual upload area, and the Create case action.
Source documents are optional at creation. Upload readable files now or create the case and add them later.

What happens next

  • A case with documents can enter drafting; a case without them waits for documents.
  • Facts extracted from source material still need confirmation or expert review.
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Official references

This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.

European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices