IVDR Transition: Australia and Switzerland Align With the European Union
In recent years, both Australia and Switzerland have taken significant steps to harmonise their regulations with the European Union, in particular the IVDR Regulation (EU) 2017/746 on in vitro diagnostic Medical Devices (IVDs). These efforts reflect a global trend towards IVDR compliance, ensuring greater consistency and safety in the medical device sector.
Extension of Transitional Periods for Full Application of the IVDR in the European Union
Regulation (EU) 2017/746 entered into force on May 26, 2017, and became applicable on May 26, 2022, with an initial transition period of five years. To ensure a smooth transition, transitional IVDR provisions were introduced and differentiated according to the risk class of the devices and the certification held.
The latest revision of the timeframe came with the Regulation (EU) 2024/1860, published on July 9, 2024, in the Official Journal of the European Union, to give manufacturers more time to comply and avoid shortages of essential public health devices.
Australia Extends Transitional Arrangements for IVDs
Aligning with European timelines, on January 10, 2025, the Australian Therapeutic Goods Administration (TGA) announced the extension of transitional arrangements for IVDs, allowing manufacturers to continue to use EC certificates issued under Directive 98/79/EC (IVDD) as evidence of compliance, until the following dates:
- January 1, 2028: for IVD class 4 devices (equivalent to class D in the EU).
- January 1, 2029: for IVD class 3 devices (equivalent to class C in the EU).
- January 1, 2030: for class 2 IVD devices (equivalent to class B in the EU).
Therefore, manufacturers applying to register an IVD device with the Australian Register of Therapeutic Goods (ARTG) now have more options to exploit to fulfil the ‘Manufacturer Evidence’ requirement to support an application.
These measures reduce the burden of obtaining new proofs of conformity. In addition, TGA introduced an option for manufacturers of class 2 and 3 IVDs, allowing the use of the EU IVD Declaration of Conformity (DoC) made before May 26, 2022, as Manufacturer Evidence until the specified deadlines.
Switzerland Adapts Legislation to the EU IVDR
As of January 1, 2025, Switzerland has updated the In Vitro Diagnostic Medical Devices Ordinance (IvDO), bringing it into line with recent changes in the EU IVDR. The main new features include:
- The extension of the validity of IVDD certificates until 2027, 2028 or 2029
- The gradual implementation of EUDAMED, the European database for Medical Devices.
These changes restore regulatory equivalence with the EU, ensuring greater consistency in the regulation of IVDs.
Other Countries Follow the European Example
Besides Australia and Switzerland, other countries are taking steps to harmonise their IVD regulations with the European Union’s IVDR (EU) 2017/746.
These developments confirm the global trend towards the harmonisation of regulations on in vitro diagnostic Medical Devices to ensure high safety and quality standards for patients and healthcare professionals worldwide and promote the dissemination of safe Medical Devices.
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https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/anpassung-verordnung-ivd.html
Read more about the timing of the implementation of IVDR (EU) 2017/746 in the European Union: “Extension of the IVDR transitional periods”
02/18/2025
