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Active Medical Devices

Overview​

An active medical device is any medical device that relies on a source of energy other than energy directly generated by the human body or gravity to function. This includes battery-powered devices, mains-powered devices, and software-based devices. Active medical devices have their own classification rules (Schedule 2, Part 2) and specific Essential Principles that apply to them (EP 9, 12, 12.1).

Classification of Active Devices​

Active devices are classified under Schedule 2, Part 2, based on their intended purpose and the nature of the energy they deliver or the information they process. Key considerations:

  • Active diagnostic devices — classified based on the severity of the condition being diagnosed and the public health implications of an incorrect result (Class I to Class III)
  • Active therapeutic devices — classified based on whether energy exchange with the patient could be hazardous (Class IIa or IIb)
  • Active implantable devices — now classified as Class III (following AIMD reclassification)

👉 Active & Software Devices — Classification

Key Essential Principles for Active Devices​

EP 9 — Construction and environmental properties: Active devices must be designed to minimise risks from electromagnetic interference and other environmental interactions.

EP 12 — Connected to or equipped with an energy source: Active devices must comply with the IEC 60601-1 series of standards for electrical safety. This is one of the most extensive compliance requirements for active devices.

EP 12.1 — Software: Where a device includes software or is a software-based device, IEC 62304 (software lifecycle) requirements apply in addition to the hardware electrical safety requirements.

IEC 60601-1 and the Collateral Standards​

IEC 60601-1 is the general standard for the safety and essential performance of medical electrical equipment. For active medical devices it is typically mandatory. A family of collateral and particular standards applies in addition:

  • IEC 60601-1-2: Electromagnetic disturbances
  • IEC 60601-1-6: Usability engineering
  • IEC 60601-1-8: Alarm systems
  • IEC 60601-1-9: Ecodesign requirements
  • IEC 60601-1-11: Home healthcare environments
  • Particular standards (IEC 60601-2-xx series) for specific device types

Official Sources​