The Medical Devices Regulation (2017/745/ EU) (MDR), which began to take effect on 26 May 2021, was released in May 2017 and transitioned over a period of four years. This change will also have an impact on Sponsors that provide medical devices to Australia.
The Therapeutic Goods Administration (TGA) has formulated a guidance for sponsors and manufacturers, who have registered their medical devices (inclusion) in the Australian Register of Therapeutic Goods (ARTG) using the EU MDD certification. That is, because they will be required to transition to the new EU MDR certification before continuing the supply of the products in Australia.
Due to the delays and possible changes in the updated certificate of the devices from the European notified bodies, TGA has provided a risk-based and streamlined approach for the sponsors and manufacturers to minimize the upcoming impact from the transition. Sponsors and manufacturers have the responsibility to ensure the compliance of ARTG conditions in a way of notifying TGA in the transition period. Most importantly, the valid EC certificates under EU MDD or AIMDD are accepted by TGA until their expiry date or 26 May 2024, whichever occurs first.
The new EU MDR certificates for the devices may have impacts on the current existing EU MDD certificates, such as changes in the device classification, indications, intended purpose, functional description, labelling and instructions for use. For those ARTG entries supported by the EU MDD certificates, actions from sponsors may be required to ensure continued compliance, including the update on the new manufacturer evidence. This will be processed via an application of Device Change Request (DCR) and variations, depending on the changes on the certificate of the EU MDD and the EU MDR in between. An online assessment tool and the summary of regulatory actions have been provided by TGA to assist manufacturers and sponsors with the transition.
The TGA regulatory framework has defined the procedures and frequently asked questions for manufacturers that are undergoing the transitioning to the new certification issued under the EU MDR. This includes necessary regulatory actions, if the delay in the MDR certificate for the devices included in ARTG shall occur. For more information, kindly contact us to receive assistance on your situation due to the effects of the EU transition. Our Australia registration team will be happy to answer you any questions that you may have.
- EU MDR Transition: Overview and management under the Australian regulatory framework
- Online assessment tool and online notification form