Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation

Results updated 13 Nov 2025

We asked

The Therapeutic Goods Administration (TGA) undertook a public consultation on a proposal to align the Australian Essential Principles (EPs) for medical devices, where appropriate, with the relevant European general safety and performance requirements (GSPRs). The GSPRs are specified in Regulation (EU) 2017/745 on medical devices (MDR) and Regulation 2017/746 for in vitro diagnostic medical devices (IVDR), collectively referred to as the EU Regulations. In addition, to provide additional clarity and address specific safety concerns, the consultation paper also included Australian-specific proposals. Stakeholder feedback was invited on the proposed transition arrangements for existing ARTG entries and for new or ongoing applications for inclusion.

You said

Of the 41 responses received to the consultation paper, 39% (n=16) were submitted by medical device sponsors, 24% (n=10) by hospitals, health professionals or their representative bodies, 12% (n=5) by Australian manufacturers and 7% (n=3) by overseas manufacturers. A further 5% (n=2) each came from regulatory affairs consultants, and medical device industry organisations or peak bodies. The remaining 7% (n=3) were from other stakeholders, including a research organisation, a government entity, and a consumer.

Most of the stakeholders were in favour of aligning the Australian EPs with the EU MDR and IVDR GSPRs, where appropriate, saying it would improve patient safety and give healthcare providers more confidence in device performance.

Most of the respondents representing medical device industry were in favour of alignment in principle but emphasised that the current EPs are already sufficient to ensure safety and quality. Respondents said some requirements were already in place, and concerns were raised that introducing additional requirements could lead to redundancy and unnecessary complexity, particularly in the absence of clear evidence of enhanced device safety and performance leading to consumer benefit. They stressed the need for flexibility and global alignment to avoid blocking products approved in jurisdictions outside the EU like the US, Canada, and Japan.

There was strong opposition from industry on the Australian-specific proposals, particularly those relating to labelling changes. Stakeholders indicated that the proposed requirements were overly burdensome and could lead to manufacturers withdrawing their products from the Australian market.

Some proposals were seen as impractical to implement depending on factors such as device type (e.g. Class I, IVD, self-testing, point-of-care), device size and existing legislative requirements. For example, the font size requirement for labelling may restrict inclusion of certain information that is mandatory as per existing EPs, some requirements mentioned under proposal 12 may not be applicable for self-testing IVDs, and the UDI requirement under proposal 10 does not apply to Class-I devices. Respondents also emphasised that it is the manufacturer's responsibility to determine whether specific requirements stated in some of the proposals (such as proposal 9 - legibility requirements) are applicable to their device, based on their quality management system, intended user, intended use and associated risks. Most stakeholders were in favour of keeping the requirements flexible by adding qualifiers such as ‘where possible’ and ‘where applicable’.

Almost all the proposals were supported by non-industry stakeholders, including representatives from hospitals, health professionals and their peak bodies, a government entity, and a consumer. They acknowledged the TGA’s efforts to harmonise the Australian EPs with the EU Regulations and welcomed the balanced approach. Feedback noted that it will enhance device safety, transparency, and reliability to best serve the needs of the Australian community. This cohort also recommended further consultation with manufacturers and sponsors to assess and mitigate any potential regulatory burden arising from the proposals.

Overall, the feedback emphasised the importance of user-friendly guidance to support compliance with the proposed requirements. Many respondents suggested that alignment of some proposals could be more effectively achieved through updating the guidance document, rather than updating the Australian EPs.

Most respondents supported the proposed transition periods, with 82% (n=27) in favour of a six-year period for pre-existing ARTG entries, and 78% (n=25) in favour of a four-year period for ongoing applications for inclusion. These timeframes were considered reasonable to allow manufacturers sufficient time to achieve compliance. However, some stakeholders expressed concerned about the adequacy of the proposed duration and recommended that extensions be considered to support a higher level of compliance.

The TGA will continue to engage with relevant stakeholders prior to implementation to help mitigate potential impacts on industry and Australian consumers.

For a summary of feedback on each proposal, please refer to this document.

We did

As requested by some stakeholders, we conducted a series of workshops to discuss the consultation paper and answer any related questions. A copy of the presentation, along with our responses to selected questions raised during the sessions, is available at the bottom of this page.

We are currently reviewing the feedback received and working to finalise recommendations for Government consideration. Pending the outcome of the Government’s decision, we will inform stakeholders of the next steps.