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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.

www.LabOnline.com.au | www.LifeScientist.com.au

IVD medical devices.

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