EU MDR transition extension

On 15 March 2023, the European Union extended the EU MDR transition periods. This extension is for devices transitioning to the EU MDR from 26 May 2024 to:

• 26 May 2026 for class III implantable custom-made devices
• 31 December 2027 for class III and implantable class IIb devices
• 31 December 2028 for non-implantable class IIb and lower risk devices
• 31 December 2028, for class I devices that are a higher class under the MDR.

The EU also removed its 12-month "sell-off" provision so non-transitioning medical devices that comply with the EU MDD may now be supplied in the EU, after May 2025, until the stock is depleted. The "sell-off" provision was also removed from the In Vitro Diagnostic Regulation (EU IVDR) that started on 26 May 2022, with staggered transition between 26 May 2025 and 26 May 2028. For IVDs, those transition dates stay the same.

MDD notified bodies will not re-issue MDD certificates with extended expiry dates. Rather, the EU MDR unilaterally extends the validity of current MDD certificates if certain criteria are met.

To qualify for the EU MDR transition extension, manufacturers must:

• apply for MDR certification with an MDR notified body by 26 May 2024 and before their MDD certificate expires, and
• have a contract in place with an MDR notified body before 26 September 2024.

MDD notified bodies will continue to be responsible for ongoing oversight of manufacturers they have certified, until the manufacturer transitions to an MDR notified body.

The revised TGA strategy

Key elements of the TGA’s EU MDR transition strategy have not changed:

• Reduced application fees to supply devices with non-compliant labelling, and to update EU certificates lodged with the TGA.
• A streamlined market notification process for devices with low-risk changes due to the EU MDR, and a web publication service for sponsors wishing to notify health care providers and consumers via the TGA website.

However, the 12-month transition for sponsors to supply devices manufactured before their EU MDD certificate expired, which mirrored the EU "sell-off" deadline, no longer applies.

The TGA will now accept MDD certificates that have been extended in the EU, as new or revised Manufacturer Evidence, as detailed below:

• until 26 May 2024, we will continue to accept MDD certificates that have not expired
• we recognise that the expiry date on MDD certificates will not be updated
• until 26 September 2024, we will accept MDD certificates that are accompanied by evidence that the manufacturer has applied with a notified body for MDR certification of the device
• after 26 September 2024, we will accept MDD certificates that are accompanied by evidence that the manufacturer has a contract with a notified body for MDR certification of the device:
  • until 31 December 2027, for class III and implantable class IIb devices
  • until 31 December 2028, for non-implantable class IIb and lower risk devices.

New applications

For new applications that rely on an MDD certificate, submitted after the expiry date listed on the certificate, the sponsor will need to provide evidence that the manufacturer is eligible for extended validity under the EU MDR.

Existing ARTG entries

For existing ARTG entries that are supported by EU MDD certificates, certificates that qualify for extended validity in the EU will be considered in-force in Australia and not ‘expired’, despite the expiry date listed on the certificate. MDD certificates will not be considered in-force after 31 December 2028, or after 31 December 2027 for Class III and Class IIb implantable devices. Sponsors will not need to notify the TGA, nor submit a lapse in conformity assessment notification form, where the EU has extended the validity of the MDD certificate. However, they must provide evidence of the extended validity of the certificate if requested.

Sponsors must notify the TGA within 60 days of becoming aware of any MDD certificate that supports ARTG entries that is no longer valid in the EU. For example, if the certificate is suspended, cancelled, withdrawn or does not meet the extension requirements in the EU.

If a sponsor has no valid conformity assessment certification, then they should expect TGA compliance activity. We may contact sponsors at any time to ascertain the situation, as part of our ongoing compliance activities. The TGA will consider compliance case-by-case and may cancel or suspend an ARTG entry that no longer has conformity assessment certification.

Impact on reclassification reforms

On 25 November 2021, the reclassification of certain medical devices to align with the EU MDR came into effect. Transitional arrangements are in place to allow eligible ARTG entries to be supplied during the transition period. Sponsors must apply to include the transitional devices in the ARTG at the new classification before the transition deadline. In November 2023, regulatory amendments have been made to extend the transition deadline for some transitional devices to 1 July 2029. This allows manufacturers time to obtain MDR certification before the end of the EU MDR transition on 31 December 2028, and for sponsors to use the MDR certificate to apply to the TGA.

The transition does not apply to sponsors of any new applications for devices ineligible for transition, which must be lodged at the higher classification prior to the supply. This was in place since 25 November 2021 and has not changed.

Impact on patient-matched medical devices

Regulatory amendments have also been made to extend the transition for patient-matched medical devices (PMMD) to 1 July 2029, and to extend the notification period for manufacturers and/or sponsors (suppliers) of PMMDs from 25 August 2022 to 1 November 2024.

As per the extended timeframe, if a manufacturer and/or sponsor (supplier) intends to continue to manufacture and/or supply a PMMD on, or after 1 July 2029, a transition notification must be made to the TGA before 1 November 2024. The transition notification period for PMMDs will end on 1 November 2024.

Under the Therapeutic Goods (Medical Devices) Regulations 2002, all PMMDs will continue to be exempt from ARTG inclusion until 1 July 2029 and can be manufactured and/or supplied until this date.

After 1 July 2029, all PMMDs (including notified PMMDs) must be included in the ARTG before they are imported into, supplied within, or exported from Australia (unless they are exempt, excluded or otherwise approved by us). Exempt devices are exempt from inclusion in the ARTG, but they are not exempt from regulation. Manufacturers and sponsors of exempt medical devices still need to comply with TGA regulatory obligations for medical devices, including meeting the Essential Principles and advertising requirements.

Software reform deadline unchanged

The transition arrangement for software based medical devices will not change and the transition ends on 1 November 2024. The only exceptions to this are software based medical devices that fall within any of the reclassification reforms listed in the table below.

The updated transition deadline is summarised in the table below.

Impact on Unique Device Identifier (UDI)

We are considering the impact on the Australian implementation of the Unique Device Identifier (UDI). More information will be made available when any decisions are made.

More information

• EU MDR Transition
• Medical devices reforms