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Submissions received: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

24 October 2019

The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems.

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 three (3) submissions were received.

TGA summary

This consultation invited respondents to provide feedback on a proposal to classify surgically invasive medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) as Class III (high-risk) regardless of the duration of use and/or intended indications. The proposed changes would align the Australian classification with aspects of Rule 6 and Rule 7 (Annex VIII, Chapter III) of the EU Regulation on medical devices 2017/745 (EU MD Regulation).

The submissions provided general support for aligning with the EU MD Regulation. However, some concerns were raised about the impact of the proposal on cost and resources, and also on the scope of devices to be covered by the new classification rule. Some submissions also raised questions that were not within the scope of the consultation paper.

No major concerns were expressed about the transitional arrangements, however one submission noted that the transitional timeframes will work for devices that will be reclassified in Europe however for those products not reclassified in Europe they may not have the necessary documents to meet the Australian requirements.

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.

Submissions received

All submissions that gave permission to be published on the TGA website are available below in PDF format.

How to access a pdf document