TGA, Australia has published guidance on the imminent reclassification of certain medical devices.
Which medical devices are going to be reclassified?
The following medical devices are going to be reclassified:
- Medical devices in direct contact with the heart, central circulatory and central nervous systems
- some spinal implantable medical devices
From what date are these medical devices going to be reclassified?
These medical devices are going to be reclassified from 25 November 2021.
Some more information about the reclassification
What is included in the requirements for reclassification of these devices?
The requirements for reclassification include:
- more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
- conformity assessment documents demonstrating procedures appropriate:
- for a Class III device for medical devices in direct contact with the heart, central circulatory and central nervous systems
- for their classification, for spinal implantable medical devices
- mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence
Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems
From 25 November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.
This reclassification will occur regardless of the duration of action of the device (transient, short-term or long-term). This means that:
- medical devices used in direct contact with the heart and CCS which are intended for transient or short-term use will be reclassified from Class IIa (low-medium risk) to Class III (high risk)
- medical devices used in direct contact with the CNS which are intended for transient use will be reclassified from Class IIa to Class III.
Some examples of transient and short-term surgically invasive medical devices used in direct contact with the heart and/or CCS include:
- self-expanding valve prosthesis post-dilatation balloon catheter
- cardiac vent catheter
- central venous catheterisation kit
- cardiopulmonary cannulae.
Some examples of transient-use surgically invasive medical devices used in direct contact with the CNS include:
- flexible fibreoptic neuroscope
- rigid neuroscope
- automatic cranial perforator
- spinal needle.
Reclassification of spinal implantable medical devices
From 25 November 2021, some spinal implantable medical devices will be required to be reclassified.
The classification of your spinal implantable medical device will determine the safety and performance requirements to be demonstrated to meet regulatory requirements.
All spinal implantable medical devices are currently classified as Class IIb medical devices under the Therapeutic Goods (Medical Devices) Regulations 2002.
On 12 December 2019, the Regulations were amended in relation to a number of medical devices, including the classification of some spinal implantable medical devices.
The amendments include the reclassification of motion-preserving devices (such as spinal disc replacements and devices used to help restore the normal motion of the spine) and spinal implantable devices that come into direct contact with the spinal column, to Class III , effective from 25 November 2021.
This means that devices that articulate and preserve the motion of the spine will be reclassified to Class III.
What will determine the action that sponsors need to take regarding this reclassification?
If you are a sponsor of any of these devices, the action you will need to take to comply with the new regulations will depend on the status of your product i.e.:
- Medical devices included in the ARTG prior to 25 November 2021
- Applications to include a medical device in the ARTG lodged before 25 November 2021
- Applications to include a new medical device in the ARTG on or after 25 November 2021
Where can you find further information concerning the reclassification?
Further detailed information is available in the following guidance documents:
Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems, Guidance on the transitional arrangements and obligations is available here.
Reclassification of spinal implantable medical devices, Guidance on the transitional arrangements and obligations of sponsors and manufacturers is available here.