This article deals with the TGA regulations will acknowledges the prolonged transition period for the EU Medical Device Regulation. The EU extended the EU MDR transition period (external site for devices moving to the EU MDR) from May 26, 2024, to March 15, 2023. The acknowledged TGA regulations are
- For class III implanted devices, the deadline is May 26, 2026.
- For class III and implanted class IIb devices, December 31, 2027
- 31 December 2028 for class IIb and lower-risk devices that are not implanted
- 31 December 2028 for class I devices, which fall within the MDR’s higher class.
The EU eliminated its 12-month “sell-off” section for non-transitioning medical devices that adhere to the EU MDD, allowing for a gradual transition beginning in May 2025 and continuing until the stock is exhausted. The IVD Regulation went into effect on May 26, 2022, with a changeover date for IVD medical devices. The EU MDR unilaterally extends the validity of current MDD certificates if certain criteria are met, such as – Before their MDD certificate expires on May 26, 2024, they must apply for MDR certification through an MDR-notified body and have a contract in place with an MDR-notified body by September 26, 2024.
The TGA has updated its approach to allow manufacturers to adjust to the new transition. They include
- Reduced application fees for providing products with incorrect labelling and for updating TGA-filed EU certifications.
- The EU MDR provides a shortened market notification process, an external site, and a web publication option for sponsors to alert consumers and healthcare practitioners.
The 12-month transition period, which paralleled the EU “sell-off” date and allowed sponsors to deliver devices made before their EU MDD certificate expired, is no longer in effect. The TGA will now accept MDD certificates extended in the EU as new or revised evidence as below
- We will continue to accept valid MDD certifications until May 26, 2024.
- MDD certificates cannot be updated to reflect this.
- MDR certificates will be accepted until September 26, 2024, provided there is evidence that the manufacturer has applied for MDR certification.
- MDD certifications will be accepted after September 26, 2024, provided the maker agrees to have an agreement with the authority for the device’s MDR certification.
To know more about how this regulation will impact your medical device sales in Australia, click here
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