Australian medical device regulations alignment with the EU – April 2023

Since the 2015 Expert Review of Medicines and Medical Devices Regulation, the TGA has been making changes to the Australian regulations to align with the latest EU MDR and IVDR

By Val Theisz

The first Australian medical device regulations were published in 2002. They were modelled on the EU Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD), and the Global Harmonization Task Force (GHTF) guidance documents published at the time. The Australian medical device regulations cover medical devices, active implantables, and IVDs.

While not identical with the EU directives or the GHTF guidance documents, the Australian medical device regulations introduced similar key regulatory framework elements such as:

• the definition of essential principles of safety and performance
• the definition of general risk classification rules, based on criteria such as:
  • duration of use
  • whether a device is invasive or not
  • whether the device is ‘active’ or not (i.e., operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity)
  • whether the device come in contact with the central circulatory system or central nervous system
• the definition of risk-based conformity assessment pathways for pre-market assessment
• the definition of requirements for post-market compliance

Since adopting a regulatory framework based on EU regulations the TGA has accepted CE Marking approvals as basis for inclusion in the Australian Register of Therapeutic Goods (ARTG).

In 2014, an independent expert panel conducted a review of the Australian medicines and medical devices regulations. The following year year two reports were published: a Stage One Report which covered recommendations on the regulatory frameworks for medicines and medical devices, and a Stage Two Report, which covered the regulation of complementary medicines and the advertising framework for therapeutic goods.

Of the 58 recommendations made by the expert panel, 56 were accepted in full or in-principle by the Australian Government, along with a program of reform to facilitate their implementation.

Recommendation twenty stated that the regulation of medical devices should, wherever possible, be aligned with the European Union framework, and any “specific” (different) requirements should be duly justified.

Hence, the TGA has continued its policy of maintaining alignment with EU medical device regulations after the 2017 enactment of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) in the EU. The key areas where the TGA has already implemented changes are listed below:

• 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, and post-market reviews
• 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)

Alignment of regulatory frameworks does not mean identical definitions or regulatory requirements. A consequential difference between the EU and Australian definitions is the definition of central circulatory system. The Australian definition for CCS includes iliac blood vessels, whereas the EU definition does not. This has a significant implication for the risk classification and implicitly the pre-market conformity assessment.

For example, a stent implanted in the iliac artery is classified as class IIa in EU and class III in Australia. This means that a CE Marking approval from an EU notified body cannot be used as basis for inclusion in the ARTG in Australia. Class III devices require appropriate clinical data, including data obtained from clinical trials.

To avoid surprises during applications for inclusion in the ARTG, applicants are advised to check the latest TGA regulations and regulatory guidelines. If necessary, a pre-submission with the TGA should be requested to clarify any question the applicant may have.

The TGA Guidance Clinical evidence guidelines: Medical devices of June 2022 is very similar with the EU MDR Annex XIV and the EU MDCG guidelines 2020-5, 2020-13, and 2021-28. A supplementary document provides guidance for clinical evidence required for IVDs.

Since October 2020, the TGA has implemented a new Post Market Review Compliance Dashboard which replaces the previous process of responding to a post-market review and sending associated documentation by email to the TGA. This is expected to enhance post-market data analytics and facilitate a more transparent, efficient, and secure way in which the TGA can notify sponsors of post-market reviews of medical devices.

Other alignment efforts are the implementation of a UDI system which is currently underway. In July 2022, the TGA has launched a so-called ‘Sandpit’ version of the Australian UDI Database (AusUDID). The Sandpit has been provided as an early release for users to provide feedback on the usability and design of the future AusUDID.

At the time of writing this newsletter, the Sandpit is open to all those who are interested in helping the TGA test the AusUDID and provide their feedback.

For more information on the medical devices reforms and their implementation progress, check the TGA website: https://www.tga.gov.au/products/medical-devices/medical-devices-overview/medical-devices-reforms