Latest developments in medical device regulations in Australia – Part 1

Are the Australian regulations for medical devices aligned with the new EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation?

The first Australian medical device regulations were published in 2002. They were modeled on the EU medical devices directive and GHTF guidance documents, and covered medical devices, active implantables and IVDs. While not identical with the EU directives, the key similarities include definition of essential principles of safety and performance, risk classification rules, risk-based conformity assessment pathways for pre-market assessment, and requirements for post-market compliance.

TGA’s policy of alignment with EU medical device regulations has continued with the 2017 enactment of the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation in the EU. For example, the TGA has taken steps to align the Australian medical device regulation with the MDR and IVDR in the following areas:

• Medical device software
• Personalized medical devices
• Systems or procedure packs
• Patient implant cards (PIL) and patient information leaflets (PIL) – similar to EU MDR Article 18
• Self-testing IVDs, IVD companion diagnostics
• Stronger post-market monitoring
• Reclassification of certain medical devices: mesh implants, spinal implants, medical devices administering medicines and biologics by inhalation, MDs in direct contact with the heart, the central circulatory system (CCS), or the central nervous system (CNS)
  
  

Note that the Australian definition for CCS includes iliac blood vessels, whereas the EU definition does not, which means for example a stent implanted in the iliac artery is class IIa in EU and class III in Australia.

Other alignment efforts are the implementation of a UDI system which is currently underway.