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EP 7–15 Design & Construction

Overview​

Essential Principles 7 to 15 are the design and construction principles that apply on a case-by-case basis depending on the characteristics of the specific device. While EPs 1–6 apply to all devices, EPs 7–15 apply only where relevant to the device's type, materials, function, or intended use. Manufacturers must assess each principle and document whether it applies — and if so, provide evidence of compliance.

EP 7 — Chemical, Physical and Biological Properties​

Applies to: Hardware devices (not software)

What it requires: Devices must be designed and manufactured with particular care regarding the choice of materials, especially as regards toxicity, biocompatibility, flammability, and mechanical properties. Materials that come into contact with the patient's body must be biocompatible.

In practice: Biocompatibility testing is required for patient-contacting materials, following the ISO 10993 series of standards. Chemical characterisation of materials must be documented. For devices incorporating animal-derived materials, additional requirements under EP 7 and specific classification rules apply.

Relevant standards: ISO 10993 series (biocompatibility), ISO 22442 (animal tissues)

EP 8 — Infection and Microbial Contamination​

Applies to: Hardware devices (not software), particularly those supplied sterile or intended to reduce the risk of infection

What it requires: Devices must be designed, manufactured, and packaged to reduce the risk of infection to the patient, user, and third parties. For devices supplied sterile, the sterile barrier system must be validated. For devices intended to reduce microbial contamination (such as antimicrobial coatings), performance must be validated.

In practice: Sterilisation process validation is required for sterile devices (ISO 11135 for ethylene oxide, ISO 11137 for radiation, etc.). Sterile barrier packaging must be validated (ISO 11607). Devices intended for reuse must have validated reprocessing instructions.

Relevant standards: ISO 11135, ISO 11137, ISO 11607, ISO 17664

EP 9 — Construction and Environmental Properties​

Applies to: All devices

What it requires: Where a device is intended to be used in combination with other devices or equipment, the combination must be safe. Devices must be designed to minimise risks from electromagnetic interference, electrostatic buildup, pressure risks, and other environmental factors.

In practice: For electrical devices, compatibility with other electrical systems must be demonstrated. EMC (electromagnetic compatibility) testing is typically required for active devices. Devices used in specific environments (MRI, explosive atmospheres) have additional requirements.

Relevant standards: IEC 60601-1-2 (EMC), IEC 60601-1 (general active device safety)

EP 10 — Medical Devices with a Measuring Function​

Applies to: Non-IVD devices with a measuring function (e.g., blood pressure monitors, thermometers with medical claims)

What it requires: Devices with a measuring function must be designed and manufactured to provide sufficient accuracy and stability. The scale must be designed ergonomically and measurements must be expressed in Australian legal units of measurement (or approved alternatives).

In practice: Measurement accuracy must be validated and specified. Uncertainty of measurement must be documented. Calibration requirements and intervals must be stated in labelling and instructions.

EP 11 — Protection Against Radiation​

Applies to: Devices that generate radiation (X-ray equipment, lasers, ultrasound, MRI)

What it requires: Devices must be designed and manufactured to minimise exposure to radiation for patients, users, and third parties, while still enabling the device to perform its intended diagnostic or therapeutic function. Unintended radiation must be minimised. Users must be informed about residual radiation risks.

In practice: Radiation protection testing and risk assessment are required. Devices must comply with applicable radiation standards for the type and application of radiation generated.

EP 12 — Medical Devices Connected to or Equipped with an Energy Source​

Applies to: Active medical devices (powered devices)

What it requires: Active devices must be designed and manufactured to avoid risks from electrical faults, fire, mechanical hazards, noise, vibration, and hazardous substances. Devices must be safe under both normal and fault conditions.

In practice: Active devices must comply with the IEC 60601-1 family of standards (general electrical safety for medical devices), as well as relevant collateral standards (e.g., IEC 60601-1-2 for EMC, IEC 60601-1-6 for usability, IEC 60601-1-8 for alarms) and particular standards for the specific device type.

Relevant standards: IEC 60601-1 series

EP 12.1 — Software (Programmed or Programmable Devices)​

Applies to: Software-based medical devices

What it requires: Software must be developed, validated, and maintained in accordance with the state of the art in software development. This includes requirements for reliability, security (cybersecurity), safety, and performance validation. Software must be designed to prevent and detect errors and must be validated in its intended operating environment.

In practice: Software lifecycle requirements follow IEC 62304. Cybersecurity requirements have been significantly expanded — the TGA published detailed cybersecurity guidance that manufacturers must consider. Software must be validated against defined requirements and its performance must be monitored post-market. Version control and change management processes must be documented.

Relevant standards: IEC 62304 (software lifecycle), IEC 60601-1-6 (usability), TGA cybersecurity guidance

EP 13 — Information to be Provided with a Medical Device​

Applies to: All devices

What it requires: Each device must be accompanied by adequate information to allow safe and effective use. This includes labelling on the device and its packaging, instructions for use (IFU), and where applicable patient information leaflets, patient implant cards, and UDI information.

In practice: Labelling must include specific mandatory elements under EP 13 and TGA labelling requirements. IFUs must be clear, accurate, and comprehensive. For software, information may be provided electronically. Patient implant cards are required for implantable devices.

Note: EP 13.2(3) specifies that for software, information can be provided electronically; for hardware, information must be on a physical leaflet.

EP 13B — Software Version and Build Numbers​

Applies to: Software-based medical devices

What it requires: The current version and build number of the software must be identifiable and accessible by users and must be presented in English.

In practice: Version information must be clearly accessible within the software interface and documented in labelling or IFU.

EP 14 — Clinical Evidence​

Applies to: All devices

What it requires: Every medical device must be supported by clinical evidence appropriate to its use and classification, demonstrating that the device meets the relevant Essential Principles. Clinical evidence must show the device performs as intended and that benefits outweigh risks.

In practice: The type and volume of clinical evidence required scales with device class and novelty. For Class I devices, existing published literature may be sufficient. For Class III and AIMD devices, comprehensive clinical evaluation reports including clinical trial data are typically expected.

👉 Clinical Evidence — What is Required

EP 15 — Principles Applying to IVD Medical Devices​

Applies to: IVD medical devices only

What it requires: IVDs must be designed and manufactured so that their analytical and clinical characteristics support the intended use. This includes requirements for accuracy, precision, sensitivity, specificity, stability, and control of known interferences. For IVDs relying on calibrators or control materials, traceability of assigned values must be assured.

In practice: Performance characteristics must be validated and documented. Performance evaluation studies must demonstrate that the device meets stated performance specifications. For high-risk IVDs, clinical utility must be demonstrated.

Official Sources​