Australia: EU MDR Transition: Overview of Australia Regulatory Framework Management

ARQon
May 25, 2023
2 min read

Updated: Jun 1, 2023

The transition between MDD into MDR certifications has affected a few requirements such as device classification, medical device labeling, functional description and the indication of use. While most of the medical devices registered under the Australian Register of Therapeutic Goods (ARTG) are supported by the EU certification, the regulation changes and possible delays in notification by the EU might cause regulatory burden, cost increment and supply shortage in the market. These devices will need to transition by 26 May 2024 to the new EU MDR certification to continue supply.

Besides, there will be new regulatory actions that will be implemented for any medical device inclusion under ARTG which are manufacturer evidence updates, new medical device applications, various ARTG entries, product recalls and market notifications. Hence, the Therapeutic Goods Administration (TGA) has come out with a new guidance framework in order to minimize the possible issue that may occur.

There are 3 main regulatory actions prepared by TGA which are:

Guidance Material
Online Assessment Tool
Online Notification Form

Guidance Material attached in the TGA’s website may guide manufacturers to gain an understanding of the regulatory framework and transition of EU MDR. TGA prepares online Assessment Tools and Online Notification Forms so that manufacturers may continue to supply medical devices in Australia. Online assessment tool also helps manufacturers to determine which action should be taken based on the changes in the conformity assessment documents. Meanwhile, the Online Notification Form will be available for qualified manufacturers to undergo streamlined market notifications and use EU MDR Web Publication Service. Streamlined Market Notifications serve its purpose to notify customers about the MDD certified products that are already in the market and unlikely involve in adverse events. Manufacturers or sponsors are not required to submit separate recall notifications other than TGA Recalls.

Source: Therapeutic Goods Administration