Submissions received for proposed reclassification of spinal implantable medical devices

Publication of submissions to the public consultation paper proposed reclassification of spinal implantable medical devices.

Published

23 October 2019

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The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed reclassification of spinal implantable medical devices.

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 eight (8) submissions were received.

Summary

This consultation invited respondents to provide feedback on a proposal for the reclassification of spinal disc replacement implants and implantable devices that come into contact with the spinal column (with the exception of screws, wedges, plates and instruments), from Class IIb (medium-high risk) to Class III (high risk).

The proposed reclassification would align the Australian classification of these devices with Rule 8 (Annex VIII, Chapter III) of the EU Regulation on medical devices 2017/745 (EU MD Regulation).

There was in-principle support for aligning with the EU MD Regulation.

However, submissions expressed differences in views regarding interpretation of the classification rule, specifically the scope of devices to be reclassified to Class III.

Some stakeholders suggested that all spinal fusion instrumentation (e.g. screws, plates, rods, cages, hooks, etc.) have the same level of risk and therefore they should remain as Class IIb.

No major concerns were expressed about the transitional arrangements, although some submissions from industry suggested extending the transition period for up to six months after the end of the transition period in Europe (i.e. until November 2024).

Post-consultation workshop

Following consideration of the submissions, the TGA invited stakeholders who provided responses to this consultation to a workshop to further discuss the scope of devices to be reclassified to Class III. In particular, the difference in the primary functionality and respective risks between non-fusion, motion-preserving spinal implants and fusion spinal devices (such as screws, plates, rods, cages, hooks, etc.) was discussed and clarified. It was proposed that the classification rule should be redrafted to make it explicit that non-fusion, motion-preserving spinal implants be reclassified to Class III, but fusion spinal devices such as cages (including expandable cages), screws, plates, rods, hooks and similar devices will remain as Class IIb devices in the Australian regulatory context.

It was also discussed that in order to ensure that there is transparency about specific devices being supplied under the Class IIb ARTG entry, the ARTG inclusion application form should be amended to require sponsors to specify all devices of the kind (with individual unique product identifiers/UPI) in the application. In addition, the TGA should select pre-market authorisation applications for Class IIb spinal devices for audit (i.e. level 1 or level 2 audit) to ensure the devices are safe for use.

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.