Australia: TGA Recognition on EU MDR Transition

The European Union consented to extend the European Union Medical Device Regulation (EU MDR) transition based on the concerns proposed by the European Commission (EC). The staggered extension for the medical devices was provided starting from 26 May 2024 up until 31 December 2028, depending on the medical devices’ classification, and removed the “sell-off” provisions for medical devices. Meanwhile, the MDD certification would not be re-issued, instead, the EU allows for validity extension by terms and conditions.

The Therapeutic Goods Administration of Australia (TGA) adapted to the transition by reducing application fees for supplying devices and updating EU certification to TGA and providing a streamlined platform for the market notification process and web publication service via the TGA website.

There will be a new acceptance schedule for MDD certifications accepted by the TGA applied for both new and revised Manufacturer Evidence.

• Until 26 May 2024: TGA still accepts valid MDD certificates

• Until 26 September 2024: TGA still accepts MDD certificates with the evidence of MDR certification application.

• After 26 September 2024: TGA will accept MDD certificates with the evidence of a sealed MDR certification contract with the Notified Body, for Class III and implantable Class IIb (until 31 December 2027) and for non-implantable Class IIb and lower-risk devices (until 31 December 2028).

MDD certificates were still enforced until 31 December 2028, or earlier for Class III and Class IIb implantable devices, 31 December 2027. The evidence of certificate validity is required if requested. Sponsors should be prepared for any requests call from the TGA and send feedback in order to prevent an entry suspension. Sponsors also require to notify TGA within 60 days before MDD certificate validity expires.

As for now, TGA is considering advising the Government of Australia regarding the timeline transitions needed in order to adapt to the EU MDR transition.

Source: TGA

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