Amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs)

17 October 2014

On 3 May 2013 the TGA released a consultation paper, Proposed Amendments to the New Regulatory Framework for In Vitro Diagnostic Medical Devices (IVDs) to address a number of the issues of concern to the IVD sector (both commercial industry and testing laboratories). The consultation paper presented proposals to address four key issues identified during the transition period. These were:

  • the transition timeframe;
  • conformity assessment procedures for Class 4 in-house IVDs;
  • the ability of the TGA to undertake performance testing for Class 4 IVDs; and
  • the regulation of IVDs used for testing for predisposition and susceptibility to disease.

The TGA has finalised a RIS recommending amendments to the framework taking into account the outcomes of the entire consultation process and the public health risks of failing to address the areas of concern. Overall, the amendments aim to reduce some of the regulatory burden introduced with the new framework and clarify the existing requirements.

Separate to the RIS was the proposal to extend the implementation timeframe for the new regulatory framework. New deadlines to demonstrate compliance with the IVD regulatory framework were implemented on 1 July 2014 through amendments to the Therapeutic Goods (Medical Devices) Regulations 2002.

Summary of proposed changes

Regulatory requirements for Class 4 in-house IVDs

Laboratories that manufacture Class 4 in-house IVDs are experiencing difficulties complying with the new regulatory requirements. Under the current arrangements, laboratories that develop Class 4 in-house IVDs are subject to the same requirements as commercial Class 4 IVDs and must obtain a TGA conformity assessment certificate for the quality management system (QMS) and separate design examination certificates for each individual IVD.

Under the proposed amendments a new conformity assessment procedure will apply to all Class 4 in-house IVDs, including those developed de novo or modified from a registered commercial IVD. Under the new procedure laboratories that develop Class 4 in-house IVDs can choose to obtain the following as evidence of an acceptable QMS:

  • maintain a TGA GMP licence; or
  • NATA accreditation as a medical testing laboratory to ISO 15189; or
  • TGA conformity assessment certification.

Laboratories that do not have a TGA GMP licence or NATA accreditation to ISO 15189 will be required to apply for TGA conformity assessment by 30 June 2016.

Laboratories that have a TGA GMP licence or NATA accreditation to ISO 15189 will be required to apply for inclusion of their Class 4 in-house IVDs in the Australian Register of Therapeutic Goods (ARTG) by 30 June 2017. Upon application they will be selected for a mandatory application audit for assessment of compliance with the essential principles. The fees charged for evaluation will be commensurate with the work to be undertaken by the TGA.

Post market monitoring and compliance requirements will continue to apply for all medical devices approved for supply in Australia.

This new approach is expected to be associated with a commensurate reduction in the applicable regulatory burden and associated costs as well as providing a more flexible and streamlined approach for laboratory manufacturers of IVDs while still maintaining a high level of quality and safety. The fee associated with a mandatory audit for a Class 4 in-house IVD is yet to be finalised and the proposed fee is expected to be included in a cost recovery impact statement that will be released by the TGA in 2015.

Regulatory requirements for commercial IVDs

The RIS examines the need for amendments to the regulatory requirements for Class 2 - 3 commercial IVDs manufactured in Australia. Under current arrangements Australian medical device manufacturers must seek a conformity assessment certificate from the TGA if they want to supply their products in Australia.

The TGA has finalised a separate RIS to streamline the conformity assessment requirements for Australian medical device manufacturers. From late 2014, Australian manufacturers of lower risk IVDs will no longer be required to obtain TGA conformity assessment certification.

This change means that Australian manufacturers of Class 2 and Class 3 IVDs will be able to rely on the same types of manufacturers' evidence already accepted for overseas manufacturers. Manufacturers of Class 4 IVDs will continue to require TGA conformity assessment certification, as is already the case for Class 4 IVDs manufactured overseas.

The RIS also proposes to reduce the regulatory burden for Class 4 commercial IVDs by allowing manufacturers to provide acceptable evidence of QMS conformity assessment certification from a European notified body (i.e. third party QMS conformity assessment). However, any further progress of these modifications is reliant on confidence building activities to be undertaken with overseas notified bodies. This process will be progressed separate to the other reforms addressed through this RIS.

Regulatory requirements for Class 1 - 3 in-house IVDs

Laboratories that manufacture Class 1-3 in-house IVDs have also been experiencing difficulties complying with the new regulatory requirements. In particular, some non-medical testing laboratories (eg, public health laboratories, animal health laboratories) that manufacture critical Class 1-3 in-house IVDs are accredited to ISO 17025 rather than ISO 15189.

The Class 1-3 in-house IVD conformity assessment procedure will be modified to allow the acceptance of NATA accreditation to ISO 17025 as evidence of an appropriate QMS as an alternative to ISO 15189. Acceptance of accreditation to ISO 17025 would, however, only be considered where it is in the interests of public health to do so. Laboratories will still be required to comply with the NPAAC standard for the development and use of in-house IVDs.

The Class 1-3 in-house notification process will also be modified to more closely align with the process of grouping IVDs of the same 'kind' for commercial suppliers. Under the modified notification process, laboratories will be required to provide the TGA with a declaration of conformity (DoC) that the in-house IVDs comply with the essential principles and describe the 'kinds' of IVDs manufactured. Laboratories would only be required to renotify the TGA if the details on the declaration of conformity were changed.

These reforms are expected to simplify the conformity assessment procedure and offer laboratories greater flexibility in the way in which they comply with the Regulations for lower risk Class 1-3 in-house IVDs while still maintaining the quality standards for these devices.

Performance evaluation of Class 4 IVDs

Prior to the commencement of the new IVD framework, IVDs for HIV and HCV required registration in the ARTG. The pre-2010 Regulations required practical laboratory performance testing of sample IVDs (for HIV and HCV) to be undertaken as part of the assessment of applications for registration to confirm that a product met the manufacturer's intended purpose and performance claims.

Under the current regulatory framework the TGA has no legal remit to request premarket performance evaluation of a Class 4 IVD to independently verify the manufacturer's performance claims. Consequently performance testing results cannot be taken into consideration by the TGA when making a decision with respect to an application for design examination CA certificates. The RIS examined the need for performance evaluation of Class 4 IVDs and options for implementation.

Following a review of the options no changes will be made to the legislative remit to allow performance evaluations of Class 4 IVDs to be undertaken. The TGA has considered whether public safety would be impacted and has come to the conclusion that that it would not be, as the TGA will maintain the ability to undertake independent performance testing of specific high risk products in the post market environment, if required, to confirm the manufacturer's claims and ensure the quality, safety and performance of an IVD on the Australian market.

Amending the definition of medical device to include predisposition and susceptibility testing

Tests that are used to determine predisposition or susceptibility to a disease or condition meet the definition of an IVD however they do not meet the definition of a medical device and are therefore not subject to regulation as an IVD medical device. Consequently, these IVDs, the majority of which are genetic tests, would continue to be regulated under the pre-existing framework and, the majority of these products would be exempt from the requirement to be entered in the ARTG and premarket scrutiny which is inconsistent with other IVDs (with a comparative level of risk).

The omission of these products from the definition of a medical device was an oversight as the inclusion of genetic testing was clearly articulated in the 2004 regulatory impact statement for the introduction of the new IVD regulatory framework.

Regulatory amendments will be made to ensure that IVDs used to test for predisposition or susceptibility are to be included within the definition of a medical device and are required to be included in the ARTG.

Exemptions for IVDs in the interests of public health

The RIS examined the need for amendments to the exemption provisions to ensure the continued supply of critical IVDs used to deal with public health emergencies or for other special purposes and circumstances.

The TGA continues to work to ensure the continued availability of critical IVDs. At this stage it is not clear if regulatory amendments are required however the TGA will be clarifying existing guidance material in relation to exemptions for IVDs.

Classification of IVDs used to test for transmissible agents included in the Australian National Notifiable Diseases Surveillance System (NNDSS) list

Under classification rule 1.3, an IVD intended to detect a pathogen listed on the Australian National Notifiable Disease Surveillance System List is automatically deemed to be a Class 3 IVD. This list is not controlled by the TGA and any addition to the list may result in the up-regulation of a Class 2 IVD to a Class 3 IVD without any industry consultation.

The classification rule will be amended to ensure that the regulatory responsibility for determining 'What is a Class 3 IVD?' resides with the TGA and that any up-classification of an IVD occurs only after appropriate consultation.

Timeframe for reforms

Regulatory amendments to implement the changes are being prepared. It is expected that the regulatory amendment to ensure that tests used to determine predisposition or susceptibility to a disease or condition are captured under the definition of a medical device will be in place by the end of 2014. The remaining amendments are expected to be put in place during the third quarter of 2015.

TGA contact

For further information please contact the TGA by email at devicereforms@tga.gov.au.