On March 15, 2023, the EU extended the EU MDR transition periods and removed the 12-month 'sell-off' provision. Non-transitioning medical devices complying with the EU MDD can be supplied in the EU until May 2025 or until the stock runs out. As a result, the TGA has revised its strategies as detailed below:
- ● The 12-month transition for supplying devices manufactured before EU MDD certificate expiry no longer applies.
- ● The TGA accepts extended EU MDD certificates as new Manufacturer Evidence until May 26, 2024.
- ● Until September 26, 2024, the TGA accepts MDD certificates if the manufacturer has evidence of MDR certification application.
- ● After September 26, 2024, the TGA accepts MDD certificates if the manufacturer has a contract with a notified body for MDR certification.
- ● For new applications with expired MDD certificates, eligibility for extended validity under EU MDR must be proven.
- ● ARTG entries supported by qualifying MDD certificates are considered valid in Australia until specified dates.
- ● Sponsors must notify the TGA within 60 days if an MDD certificate is no longer valid in the EU.
- ● Compliance actions may be taken by the TGA if a sponsor lacks valid conformity assessment certification.
Additionally, the EU has reclassified certain medical devices to align with the MDR. Sponsors must lodge new applications for these devices at the higher classification. Existing ARTG entries must be upgraded by sponsors who notified the TGA before May 25, 2022, before November 1, 2024. Failure to upgrade will result in cancellation of lower classification entries.
The TGA is reviewing the impact of the EU MDR transition extension on Australia's reclassification and personalized medical device reforms. Recommendations on transition timeframes and the implementation of the Unique Product Identifier (UPI) will be provided later.