SaMD Risk-Based Classification

Software as a Medical Device (SaMD) is subject to classification based on the risk it poses to the patient. This classification determines the regulatory pathway that the SaMD must undergo to ensure safety and effectiveness. The general principle is that higher-risk devices require more stringent regulatory controls.

General Classification Principles

• The classification of a medical device, including SaMD, is generally linked to its risk.
• Generally, risk increases with the potential harm to the patient if the device does not perform as intended.
• Classification systems vary somewhat by regulatory jurisdiction (e.g., US FDA, EU MDR), but they generally follow a similar tiered approach.

SaMD Classes

While specific classification rules can be complex and vary by region, here’s a simplified overview based on the provided images and general principles:

Class I (Low Risk)

• Generally regarded as low risk.
• Examples include software collecting and transmitting data for use by a clinician, but not to inform immediate treatment decisions.
• Non-invasive devices.

Class II (Moderate Risk)

• Generally regarded as medium risk. This class is often further divided.
• Class IIa:
  • Active therapeutic devices administering/exchanging energy (unless involving the human body in a hazardous manner).
  • Active devices intended for diagnosis.
  • Example: Software collecting and sending psychological symptoms to clinicians for use in diagnosis.
• Class IIb:
  • Active therapeutic devices administering/exchanging energy involving the human body in a potentially hazardous manner.
  • Devices intended for direct diagnosis of vital physiological processes where variations could result in immediate danger.
  • Devices used for contraception or prevention of sexually transmitted diseases.
  • Example: Software providing direct diagnosis of sepsis.

Class III (High Risk)

• Generally regarded as high risk.
• Examples include software that drives the use of an implantable pacemaker.
• Devices that sustain or support life.

Software’s Role in Device Classification

The role of software in a medical device can influence its classification:

• If software drives or influences the use of a physical device, it generally assumes the classification of that physical device.
  • “Driving” refers to software directly modifying the physical device’s action or use.
  • “Influencing” refers to software data being fed into a device to modify its action or use.

Important Considerations

• This is a simplified overview. Actual classification requires consulting the specific regulations of the relevant jurisdiction.
• The intended use of the SaMD, as defined by the manufacturer, is crucial in determining its classification.
• Manufacturers must carefully evaluate the risks associated with their SaMD, including the probability and severity of potential harm.

References

1. Medicines and Healthcare products Regulatory Agency. (2023, March 22). Crafting an intended purpose in the context of software as a medical device (SaMD). Retrieved from https://www.gov.uk/government/publications/crafting-an-intended-purpose-in-the-context-of-software-as-a-medical-device-samd/crafting-an-intended-purpose-in-the-context-of-software-as-a-medical-device-samd
2. Greenlight Guru. (2024, May 16). SaMD (Software as a Medical Device): A beginner’s guide. Retrieved from https://www.greenlight.guru/blog/samd-software-as-a-medical-device