Feb 21, 2019

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Australian TGA proposing up-classifying spinal implant devices based on European MDR rules;
  • Targeted devices would move from Class II to Class III under proposed rule;
  • TGA accepting comments on proposed rule until March 31, 2019.

Australian medical device regulators may reclassify some spinal implant devices according to European Medical Devices Regulation (MDR) rules to better reflect these devices’ risk profiles.

The Australian Therapeutic Goods Administration (TGA) has issued a new consultation that proposes a new classification rule covering spinal implantable devices; such devices would be up-classified from Class IIb to Class III in Australia.

TGA’s rule would align with Rule 8 of the EU MDR. TGA posits that the MDR rule more thoroughly and explicitly addresses risks posed by these devices’ technical design, production, invasiveness and related characteristics. TGA’s proposal would adopt this rule and them make any necessary modifications so that the new requirement more appropriately suits the Australian regulatory and market environment.

TGA is accepting comment on the proposed rule changes through March 31, 2019. Although TGA has so far proposed classification changes only for spinal implantable devices, the regulator notes in the consultation that these proposed changes may eventually be applied to more categories of devices as technological and risk developments occur.

Types of spinal implant devices potentially affected

The range of devices affected by TGA’s proposed up-classification rule would include spinal cages and spinal disc replacement implants, as well as devices that contact the spinal column:

  • Anatomic facet replacement systems, or AFRS
  • Vertebral bone filler
  • Orthopedic cement
  • Bone grafts
  • Bone screw internal spinal fixation systems
  • Cervical facet joint distractors

Transition period

For affected spinal implant devices included in the Australian Register of Therapeutic Goods (ARTG) after the proposed rule change takes effect, new Class III classification requirements would start in August 2020.

For affected devices submitted to TGA for ARTG listing prior to the proposed rule change’s implementation, these products would be granted four years to transition to the new regulations.

Learn more about Australian medical device regulatory issues: