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Medical device qualification and classification
The European regulatory pathway begins with determining whether the product qualifies as a medical device and identifying the applicable classification under Annex VIII of the MDR. For medical device software, AI-enabled healthcare solutions, digital healthcare platforms, and software-driven physical devices, classification depends on the intended purpose, the role of the software in clinical decision-making, the significance of the information it provides, and the potential consequences of an incorrect output. A classification assigned in another jurisdiction may not correspond to the classification applicable in the European Union.
