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Regulatory requirements for in-house IVDs

Version 2.2, September 2018

11 September 2018

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What is an in-house IVD?

'In-house' IVDs are pathology tests that have been developed (or modified) within a laboratory (or laboratory network) to carry out testing on human samples, where the results are intended to assist in clinical diagnosis or be used in making decisions concerning clinical management.

IVDs developed in-house but supplied* outside of the laboratory or laboratory network, fall outside the definition of 'in-house'.

These are considered to be commercially supplied IVDs, and must be included in the ARTG prior to being supplied outside of the laboratory or laboratory network.

*Supply in this context means supply of the actual device, not the testing service, outside the laboratory or laboratory network.

The regulations are not limited to medical testing laboratories, but extend to all laboratories that manufacture in-house IVDs in Australia.

All tests manufactured by a laboratory for a therapeutic purpose (e.g., diagnostic tests, screening tests, tests for susceptibility or predisposition to disease; tests for monitoring a disease or exposure to toxic metals and chemicals), regardless of whether or not they attract a Medicare rebate, are still subject to the requirements of the in-house IVD regulatory framework.

In-house tests that are developed by a laboratory for research purposes only (i.e., where there is no reporting of patient/client results) are not IVDs.

In-house IVDs are defined in Regulation 1.3 of the MD Regulations, and there are three broad situations where a laboratory is considered to have manufactured an in-house IVD.

In-house IVDs developed from first principles

An in-house IVD is considered to be developed from first principles (de novo) where a laboratory or laboratory network is responsible for the design and production of the in-house IVD, and includes:

  • design control through assignment of the specifications for the in-house IVD, as well as planning and development processes
  • assembly, processing and packaging of components that make up the in-house IVD
  • assigning the intended purpose through the information supplied with the in-house IVD (i.e. the instructions for use or laboratory-controlled documents)

IVDs developed or modified from a published source

These include in-house IVDs that are produced by a laboratory or laboratory network:

  • in accordance with scientific literature, or
  • from the design specifications or method for an in-house IVD manufactured by another laboratory, or
  • from the design specifications of any other source.

They also include the assembly of commercially supplied components, some or all of which may not be regarded as IVDs because they are:

  • not finished products, or
  • not presented for use as an IVD in the information provided with the device (i.e., manufacturer's labels and instructions for use) and in the advertising, or
  • marked "for research use only" (RUO), "investigational use only" (IUO) or "analyte specific reagent" (ASR).

While RUO, IUO and ASR products may be commercially supplied, they are not intended by the manufacturer to be used for an in vitro diagnostic purpose and will not be included on the Australian Register of Therapeutic Goods (ARTG).

Therefore, the use of these items to develop a test for the purpose of reporting clinical results for a patient means the test would be captured by the in-house IVD regulations.

The laboratory is responsible for one or more of the following:

  • assembly, processing and packaging of components purchased separately to produce the in-house IVD
  • assigning the intended purpose through the information supplied with the in-house IVD (e.g. the instructions for use, laboratory-controlled procedures)
  • supplying the in-house IVD under the laboratory's name (e.g. ABC Pathology Legionella total antibody assay).

*Supply means making the test available and reporting patient/client results of the test.

Modifications to commercially supplied IVDs

Commercially supplied IVDs become in-house IVDs when:

  • they are used for a clinical purpose other than that intended by the manufacturer
  • a physical component of the commercial IVD is modified, substituted or removed
  • the IVD is not used in accordance with the manufacturer's instructions for use (i.e., modifications to the instructions for use that could affect the performance of the device and would require validation).

The laboratory must document any changes made to a commercially supplied IVD, and be able to demonstrate that the changes have been appropriately validated to ensure that the assay performs safely and effectively.

Requirements for the validation of Class 1-3 in-house IVDs are specified in the National Pathology Accreditation Advisory Council (NPAAC) standard, Requirements for the development and use of in-house in vitro diagnostic medical devices.

If a laboratory imports a commercially supplied IVD directly from an overseas supplier, even when intending to modify that IVD so it becomes an in-house IVD, then the laboratory is the sponsor of the IVD.

Before importing the IVD, the laboratory must apply for inclusion of the commercial IVD in the ARTG. See the guideline Including IVD medical devices in the ARTG on our website.

Examples

Modifications that then create an in-house IVD

These include:

  • dilution of a component reagent to a concentration other than that specified by the manufacturer.
  • substitution of one or more components supplied in a kit, or that are intended by the manufacturer to be used as part of the assay, with an alternatively sourced or laboratory- prepared component.
  • substitution of the manufacturer's specified controls with alternative control material.
  • modification of the cut-off value, or the calculation specified by the manufacturer for determining the cut-off value, for an assay.
  • use of a commercial IVD with a specimen type not specified in the manufacturer's instructions for use.
  • use of a monitoring assay to provide a diagnostic result.
Modifications that are NOT likely to create an in-house IVD

These include:

  • utilising variations, alternatives or optional steps included by the manufacturer in the instructions for use or other information provided with the device.
  • use of alternative controls where the manufacturer has specified in the instructions for use or other information provided with the device that these can be used.
  • use of an alternative reference range that is relevant to the test population, established using a documented process.

These types of modifications would not result in an in-house IVD for regulatory purposes, but you should ensure that any modifications are appropriately verified in accordance with the laboratory's quality management system and accreditation requirements.

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