Is reduced time to triage via telemedicine a clinical benefit under MDR?

Question

For telemedicine platforms that act as medical devices by generating data for review by a medical doctor (such as audio recordings of coughing or skin pictures), the goal is often to triage patients: (1) everything is ok, (2) non-urgent check needed, or (3) urgent check needed. This process can significantly lower the time to triage compared to traditional care, where seeing a doctor may take weeks or more.
The MDR defines clinical benefit as a "positive impact on patient management." However, existing MDCG documents do not provide clear examples or interpretations for this. Does anyone have experience with defining reduction in time to triage as a clinical benefit? Would this meet the MDR's definition of "positive impact on patient management"?

Dr. Oliver Eidel · Accepted Answer

I think you can definitely argue that reduced time to triage is a clinical benefit, since the MDR includes positive impact on patient management in its definition. The key will be how you justify and quantify this benefit. For example, if you can show with literature or stakeholder data that your platform consistently reduces waiting times, that supports your claim.
In my experience, you have some flexibility in how you substantiate this, especially if existing MDCG guidance is vague. You might not always need new clinical data if good literature or usability studies can demonstrate the benefit. It's important to clearly link your claim (faster triage) to improved outcomes or management for patients, and document your rationale thoroughly.

Is reduced time to triage via telemedicine a clinical benefit under MDR?

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