medical device framework
Do you provide any testing, or aspects of testing, on human samples? If so, the Therapeutic Goods Administration (TGA) in vitro diagnostic (IVD) medical device regulatory framework could impact you.
Do you
work
in a biological, chemical or veterinary laboratory?
What is the IVD framework?
In-house IVD regulatory requirements
The IVD framework is designed to ensure all IVD
The regulations on which the framework is based
NATA accreditation in relation to in-house IVDs
medical devices, including in-house IVD medical
are not limited to medical testing laboratories, but
Class 1–3 in-house IVDs will usually be accredited
devices, undergo a level of scrutiny commensurate
extend to all laboratories that manufacture in-house
under ISO 15189; however, where a laboratory’s
with the risks associated with their use. In-house
IVD medical devices in Australia.
main area of testing is not human pathology,
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
In summary, the TGA IVD framework requires that:
accreditation under ISO/IEC 17025 will be considered on a case-by-case basis.
• all in-house IVD medical devices must be notified to or registered with the TGA;
NATA/TGA MoU
• all Class 1-3 in-house IVD medical devices
In September 2016, NATA and the TGA signed
must be accredited by the National Association
a memorandum of understanding (MoU) which
of Testing Authorities (NATA) and notified
clarifies each party’s roles and responsibilities under
to the TGA;
the regulatory framework, with a particular focus on
• Class 4 in-house IVD medical devices must be
the cooperation and exchange of information and
requirements of the in-house IVD regulatory
registered on the ARTG.
material on matters relating to the accreditation of
framework.
Any ‘in-house’ testing conducted on human
laboratories engaged in the manufacture of in-house
IVD medical devices developed in-house but
samples that assists in clinical diagnosis or used to
supplied outside of the laboratory or laboratory
make decisions concerning patient treatment or
If you are unsure whether the testing your
network fall outside the definition of ‘in-house’.
management, and which have not been assessed
laboratory is performing falls under the TGA in-house
These are considered to be commercially supplied
by NATA and notified/registered with the TGA by
IVD medical device regulatory framework, please see
IVDs and must be included in the Australian
1 July 2017, can no longer be legally offered from
the TGA website or email devicereforms@tga.gov.au.
Register of Therapeutic Goods (ARTG) prior
this date. Further information on the regulatory
to being supplied outside of the laboratory or
requirements for in-house IVDs can be found on
NATA www.nata.asn.au
laboratory network.
the TGA website.
Republished with permission from NATA.
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IVD medical devices.
LAB+LIFE SCIENTIST - Apr/May 2017 | 49