Classify in vitro diagnostic devices based on clinical significance and patient impact for proper conformity assessment.
How do I classify software-based IVD devices under IVDR?
What makes a device Class D versus Class C under IVDR?
How do I classify companion diagnostics under IVDR?
Can self-testing devices ever be Class A or Class D?
How do I handle devices that could fall under multiple IVDR rules?
What documentation do I need to support my IVDR classification?