Crafting an Intended Purpose for Software as a Medical Device (SaMD)

Software as a Medical Device (SaMD)

As a Software Medical Device (SaMD) manufacturer, you know that regulatory compliance is key to market success. Defining the intended purpose of your SaMD is a critical step in determining its regulatory classification and conformity assessment route. But what exactly does “intended purpose” mean, and how can you ensure compliance with regulatory requirements?

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released new guidance to help SaMD manufacturers craft an intended purpose for their devices. According to the guidance, the intended purpose of SaMD should be:

  • Clear and concise
  • Based on clinical evidence
  • Specific to the SaMD
  • Aligned with the device’s risk classification

The intended purpose should also take into account the device’s intended use, which refers to the context in which the device will be used, as well as the user and patient population.

By following the MHRA’s guidance, SaMD manufacturers can ensure that their intended purpose is in compliance with regulatory requirements and that their device is classified and assessed appropriately. This can save time and resources in the long run, as well as increase the chances of market success.

So, if you’re a SaMD manufacturer, make sure to check out the MHRA guidance on crafting an intended purpose for your device here!. Stay ahead of the game and ensure your SaMD is on track for market success.


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