Does providing refractive values for glasses count as a diagnosis under MDR?

Question

Our device is an eye exam tool that calculates refractive measurements, such as + or - values for glasses or contacts, which are then used by an optometrist to issue a prescription. We are transitioning from MDD to MDR. If the device provides these values but does not itself issue a diagnosis or perform therapy, does this constitute a diagnosis under MDR? Would this impact our device's classification?

Dr. Oliver Eidel · Accepted Answer

No, your device is not performing a diagnosis in the legal sense under MDR. Diagnosis is reserved for healthcare professionals, but your device does provide information that could be used as a basis for diagnosis. If the information is only displayed to optometrists who then use their judgment to issue a prescription, it is not direct diagnosis by the device.
However, you should consider the classification implementation rule: software that drives or influences a device falls into the same class as that device. Since your software influences the use of glasses or contacts, this can affect classification.
Also, check MDCG 2019-11 for clarification: if your device is directly making diagnostic decisions, classification may change. But merely providing measurements for professional interpretation generally does not count as diagnosis.

Does providing refractive values for glasses count as a diagnosis under MDR?

1 Answer

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