Submissions received for potential reclassification of active medical devices for diagnosis and patient therapy

Publication of submissions to the public consultation paper potential reclassification of active medical devices for diagnosis and patient therapy.

Published

24 October 2019

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The TGA thanks respondents who provided a submission in response to the public consultation paper Potential reclassification of active medical devices for diagnosis and patient therapy.

This consultation was related to the implementation of the Australian Government Response to the Review of Medicines and Medical Devices Regulation (MMDR), in particular Recommendation 20 that prescribes that the regulation of medical devices in Australia, wherever possible, should be aligned with the European Union (EU) framework including in respect of the classification of medical devices.

A total of fourteen (14) submissions were received.

Summary

This consultation invited respondents to provide feedback on a proposal to classify active medical devices for therapy with an integrated or incorporated diagnostic function which significantly determines the patient management by the device (such as closed loop systems or automated external defibrillators) to Class III (high risk). The effect would be that certain active medical devices for therapy would be reclassified from Class IIa (low-medium risk) or Class IIb (medium-high risk) to Class III (high risk). The proposed reclassification would align the Australian classification of these devices with Rule 22 (Annex VIII, Chapter III) of the EU Regulation on medical devices 2017/745 (EU MD Regulation). It was also proposed that the definition of active medical device in the Therapeutic Goods (Medical Devices) Regulations 2002 (AU MD Regulations) be amended to align with the definition of active device in the EU MD Regulation.

All submissions received in response to the consultation were broadly supportive of the alignment of the classification rule. However, some submissions were opposed to the proposed reclassification of some closed loop systems, particularly continuous positive airway pressure (CPAP) machines. These respondents considered that CPAP machines are medium-risk devices due to the nature of the therapy these devices provide to patients.

Some submissions also suggested that the wording of the new classification rule should be clearly expressed ensuring the rule only covers active devices for therapy with diagnostic function, and does not extend to active devices for diagnosis and monitoring. Further, some submissions also requested guidance and clarity on the meaning of the words "significantly determines".

There were no objections to the proposed change to the definition of "active medical device". No concerns were expressed about the transition arrangements, although some respondents recommended that alignment should not take place in Australia until the new EU MD Regulation is fully implemented.

This feedback will inform the work to develop the proposed regulatory amendments. Guidance material will be prepared to provide clarification about the devices that will be reclassified as a result of the regulatory changes and about the transitional arrangements.