Australian TGA Expands EU Transitional IVDR Arrangements for New Inclusion IVD Applications

By Evan Ruby and Lori White

Manufacturers applying to register a medical device or IVD with the Australian Register of Therapeutic Goods (ARTG) now have more options to fulfill the Manufacturer Evidence requirement to support an application. As a result, manufacturers may leverage their EU CE Marking Certificate issued under the IVDD to fulfill the Manufacturer Evidence requirement until the dates listed below.

The Australian medical device regulator, the Therapeutic Goods Administration (TGA), has enacted several reforms to further advance regulatory harmonization or reliance. Manufacturers can leverage existing conformity assessment evidence issued by a comparable overseas regulator or assessment body as the Manufacturer Evidence to support an application to add a medical device or IVD to the ARTG.

Further amendments were made last year, and the TGA targets additional amendments to align with the EU regulatory system under the MDR 2017/745 and IVDR 2017/746. The most recent development in line with these efforts is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination (No. 3) 2024 (hereinafter, the Amendment Determination), which amends the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 (hereinafter, the Principal Determination).

Insertion of transitional arrangements for IVDs

In July 2024, the European Commission (EC) extended the transitional deadlines for IVDs to comply with the EU IVDR. With the Amendment Determination, the TGA has inserted the following transitional deadlines for IVDs supported by the EU IVDD and compliant with Article 110(3c) of the IVDR:

• January 1, 2028, for Class 4 IVDs (equivalent to Class D IVDs in the EU)
• January 1, 2029, for Class 3 IVDs (equivalent to Class C IVDs in the EU)
• January 1, 2030, for Class 2 IVDs (equivalent to Class B IVDs in the EU)

New option for Manufacturer Evidence for Class 2 and 3 IVDs

The Amendment Determination inserts new line items into Schedule 2 of the Principal Determination, introducing a new option for manufacturers of Class 2 and 3 IVDs to fulfill the Manufacturer Evidence requirement. Such manufacturers may now leverage their EU IVDD Declaration of Conformity (DoC) made before May 26, 2022, until the applicable deadlines noted above.

Before this amendment, manufacturers of Class 2 and 3 IVDs self-certified under the EU IVDD could leverage an ISO 13485 certification to fulfill the Manufacturer Evidence requirement, with the EU IVDD DoC serving as additional evidence. This new option lessens the burden for market access for IVDs self-certified under the IVDD, accommodating those without ISO 13485 certification.

Required evidence of compliance with Article 110(3c) of the EU IVDR

Finally, the Amendment Determination introduces a new requirement for Class 2, 3, and 4 IVD applications made before the applicable deadline that leverage either an EU CE Marking Certificate issued under the IVDD, or an EU IVDD DoC made before May 26, 2022, as the required Manufacturer Evidence. Such applications must be accompanied by evidence of compliance with the conditions to qualify for transitional arrangements set out in Article 110(3c) of the IVDR.

Acceptable evidence of compliance includes:

• A self-declaration by the manufacturer confirming that the conditions for the extension are fulfilled; or
• A ‘confirmation letter’ issued by the Notified Body stating the receipt of the manufacturer's application for conformity assessment and the conclusion of a written agreement; or
• Supporting documentation demonstrating that the manufacturer has lodged an application for conformity assessment and/or concluded a written agreement with a Notified Body by other means.

If such applications are not accompanied by evidence of compliance with Article 110(3c), they will not pass the preliminary assessment and will be refused.

While the TGA has indicated that there will need to be similar evidence of compliance with the transitional arrangements under the MDR for medical devices, they did not insert this requirement into the legislation as they did with IVDs. 

Concluding remarks

The TGA has made great strides toward international regulatory harmonization, and this Amendment Determination is another step forward in recognizing market authorization evidence from the EU.

The impact of these changes is positive overall, allowing for the inclusion of IVDs in the ARTG during the IVDR transition. By the end of the transition period, manufacturers leveraging approvals under the IVDD must have Manufacturer Evidence on file with the TGA from a comparable overseas regulator or assessment body, such as IVDR CE certification, to maintain the validity of their ARTG inclusion.