Medical Device Regulation – Australia

Meeting the Essential Principles – Design and construction

Principle 15 – IVD Medical Device

From the Therapeutic Goods (IVD Medical Device) Regulations 2002

Principle #14 – Clinical evidence requirements >>>
The Essential Principles >>>

Principles applying to IVD medical devices only
  1. An IVD medical device must be designed and manufactured in a way in which the analytical and clinical characteristics support the intended use, based on appropriate scientific and technical methods.
  2. An IVDmedical device must be designed in a way that addresses accuracy, precision, sensitivity, specificity, stability, control of known relevant interference and measurement of uncertainty, as appropriate.
  3. If performance of an IVDmedical device depends in whole or part on the use of calibrators or control materials, the traceability of values assigned to the calibrators or control material must be assured through a quality management system.
  4. An IVDmedical device must, to the extent reasonably practicable, include provision for the user to verify, at the time of use, that the device will perform as intended by the manufacturer.
  5. An IVDmedical device for self-testing must be designed and manufactured so that it performs appropriately for its intended purpose, taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in the user’s technique and environment.
  6. The information and instructions provided by the manufacturer of an IVDmedical device for self-testing must be easy for the user to understand and apply.

An IVDmedical device for self-testing must be designed and manufactured in a way that reduces, to the extent practicable, the risk of error in the use of the device, the handling of the sample and the interpretation of results.

The manufacturer must have evidence, as demonstrated by appropriate testing protocols, that the IVDmedical device (IVD) performs as intended.

There must be documented procedures in place to ensure that values assigned to controls and calibrators can be related to stated references through a chain of unbroken comparisons, thereby ensuring the ongoing accuracy of these materials.

The design and construction process for an IVDmedical device for self-testing needs to take account of the foreseeable risks which could exist for, or be created by, the device when used as intended.  This should consider where the device is intended to be used, and by whom.  Identified risks or hazards should be eliminated wherever possible, and methods established to alert and inform users of any residual hazards.

Also, where possible, the manufacturer of an IVD should consider a mechanism whereby the validity of a test result can be confirmed.  This must be simple to perform and interpret.

Medical Device Validation – Regulation. Requirements & current best Practices.

      • How to plan and implement a Validation program.
      • How to identify Validation requirements versus actual status.
      • The Life Cycle approach to Validation.
      • How to identify Validation Gaps and confirm Validation effectivity.
      • Reporting on the outcomes of Validations performed.
      • Use to develop your personal understanding.
      • Use as a support if providing training.
      • Details >>>