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Regulatory Focus™ > News Articles > 2019 > 2 > Australia Proposes to Reclassify Spinal Implants in Line With EU MDR

Australia Proposes to Reclassify Spinal Implants in Line With EU MDR

Posted 11 February 2019 | By Ana Mulero 

Australia Proposes to Reclassify Spinal Implants in Line With EU MDR

Australia’s Therapeutic Goods Administration (TGA) opened a consultation on Monday to obtain feedback on its proposal to reclassify all spinal implantable medical devices to a higher risk level.

The consultation describes the reasoning behind changing the current Class IIb classification of medium-high risk on spinal implants to Class III under a new classification rule. It comes as part of an effort to align Australia’s regulatory requirements with the new framework of the EU’s medical device regulation (MDR), including device classifications. MDR is set to come into force next year.

“While the new classification rule in the EU more appropriately reflects the intended use and the risk of medical devices, this paper considers the extent to which a similar approach will be appropriate in the Australian regulatory context, to further our aim of enhancing the smooth functioning of the medical devices market while also achieving high standards of quality, safety and performance,” TGA said.

TGA’s efforts to align with MDR and the 2022 in vitro diagnostic regulation (IVDR) are based on a report from the Australian government that accepted 56 recommendations from a 2015 panel that provided an assessment of the regulatory framework for pharmaceuticals and medical devices. The accepted recommendations from the 2015 expert panel review prompted further alignment with EU regulations.

EU MDR “introduced several amendments to the classification rules effectively reclassifying some categories of medical devices to higher risk classes, including spinal implantable medical devices,” TGA noted. “The last paragraph of EU MD Regulation Rule 8, classifies spinal implantable medical devices, specifically referring to spinal disc replacement implants and implantable devices that come into contact with the spinal column, with the exception of screws, wedges, plates and instruments,” the paper states.

Feedback on the consultation paper for spinal implants’ reclassification will be accepted until 31 March.

Consultation paper


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