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Submissions received: Proposed changes to the classification of active implantable medical devices and their accessories
The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed changes to the classification of active implantable medical devices and their accessories.
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 nine (9) submissions were received.
This consultation invited respondents to provide feedback on a proposal to classify active implantable medical devices (AIMD), their accessories, active devices intended for controlling, monitoring or influencing the performance of an AIMD and software that drives or influences the use of an AIMD as Class III (high risk). The proposed changes would align the Australian classification of these devices with aspects of Rule 8, Rule 9 and paragraph 3.3 of the Implementing Rules (Annex VIII, Chapter III and II respectively) of the EU Regulation on medical devices 2017/745 (EU MD Regulation).
It is important to note that implantable accessories and active devices intended to control, monitor or directly influence the performance of an AIMD are already classified as Class III in accordance with the Therapeutic Goods (Medical Devices) Regulations 2002, and no changes are proposed to the classification of these devices in Australia. These devices will remain as Class III.
There was broad support for aligning with the EU MD Regulation. However, some submissions suggested clarifying that only long-term invasive and implantable accessories be classified as Class III, rather than all accessories to AIMD.
No major concerns were expressed about the transitional arrangements.
Post-consultation targeted discussions
Following consideration of the submissions, the TGA further consulted targeted stakeholders who suggested that only long-term invasive and implantable accessories should be classified as Class III rather than all accessories to AIMD. The TGA sought additional details on those devices that stakeholders believed should not be classified as high-risk (Class III) medical devices (i.e. of non-implantable and not long-term surgically invasive accessories to AIMD).
Analysis and comparison of the risks associated with the information and examples provided, supports the suggestion that in regards to accessories to AIMD, only long-term surgically invasive and implantable accessories to AIMD should be classified as Class III, rather than all accessories to AIMD (Note: implantable accessories to AIMD and active devices intended to control, monitor or directly influence the performance of an AIMD are already classified as Class III).
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.
All submissions that gave permission to be published on the TGA website are available below in PDF format.
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- Consultation submission: Cochlear Limited (pdf 242kb)
- Consultation submission: Consumers Health Forum of Australia (pdf,297kb)
- Consultation submission: Medical Technology Association of Australia (MTAA) (pdf,924kb)
- Consultation submission: Medtronic Australasia Pty Ltd - Name only