- Published: 08 November 2016
Do you provide any testing, or aspects of testing, on human samples?
The TGA In vitro Diagnostic (IVD) Medical Device regulatory framework could impact on you!
What is the IVD framework?
The IVD Framework is designed to ensure all IVD medical devices, including in-house IVD medical devices undergo a level of scrutiny commensurate with the risks associated with their use
What is an “in-house” IVD medical device?
'In-house' IVD medical devices are 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.
All diagnostic tests manufactured by a laboratory, regardless of whether or not they attract a Medicare rebate, are still subject to the requirements of the in-house IVD regulatory framework.
IVD medical devices 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 Australian Register of Therapeutic Goods (ARTG) prior to being supplied outside of the laboratory or laboratory network.
In-house IVD Regulatory Requirements
The regulations, on which the framework is based, are not limited to medical testing laboratories, but extend to all laboratories that manufacture in-house IVD medical devices in Australia.
In summary, the TGA IVD framework requires that:
- All in-house IVD medical devices must be notified to or registered with the TGA.
- All Class 1-3 in-house IVD medical devices must be accredited by NATA and notified to the TGA.
- Class 4 in-house IVD medical devices must be registered on the ARTG.
Any “in-house” testing conducted on human samples that assists in clinical diagnosis or used to make decisions concerning patient treatment or management, and which have not been assessed by NATA and notified/registered with the TGA by 1 July 2017 can no longer be legally offered from this date.
Further information on the regulatory requirements for in-house IVDs can be found on the TGA website.
NATA accreditation in relation to In-house IVDs
Class 1-3 in-house IVD’s will usually be accredited under ISO 15189, however, where a laboratory’s main area of testing is not human pathology, accreditation under ISO/IEC 17025 will be considered on a case-by-case basis.
In September 2016 NATA and TGA signed a Memorandum of Understanding (MoU) which clarifies each party’s roles and responsibilities under the regulatory framework, with a particular focus on the co-operation and the exchange of information and material on matters relating to the accreditation of laboratories engaged in the manufacture of in-house IVD medical devices.
This MoU is further described in the article “Regulatory updates” in this edition of NATA News.