EU MDR transition extension

On 15 March 2023, the European Union extended the EU MDR transition periods. 

This extends the transition for devices moving to the EU MDR 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.

MDD notified bodies will not re-issue MDD certificates with extended expiry dates. 

If certain criteria are met, the EU MDR extends the validity of MDD certificates.

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

• applied for MDR certification by 26 May 2024 before the MDD certificate expired, and
• had a contract in place with an MDR notified body before 26 September 2024.

MDD notified bodies will continue to oversee manufacturers they have certified. This will be until the manufacturer transitions to an MDR notified body.
 

The TGA strategy

Key elements of our 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 us.
• 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.
• We recognise that the expiry date on MDD certificates will not be updated.
• We will accept MDD certificates as new or revised Manufacturer Evidence if the sponsor also provides 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 won't be valid: 

• after 31 December 2028, or
• after 31 December 2027 for Class III and Class IIb implantable devices.

Sponsors do not need to:

• Notify the TGA.
• Submit a lapse in conformity assessment notification form. Where the EU has extended the validity of the MDD certificate. 

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.

Sponsors without a valid conformity assessment certification should expect TGA compliance activity. 

We may contact sponsors at any time to ascertain the situation. This is part of our ongoing compliance activities. 

We will consider compliance on a case-by-case. An ARTG entry with no conformity assessment certification may be cancelled or suspended.
 

Reclassification reforms

On 25 November 2021, certain medical devices were reclassified in Australia. This was so they would align with the EU MDR.

Transition arrangements allow eligible ARTG entries to be supplied during the transition period. 

Before the transition deadline, newly classified devices must be in the ARTG.

The transition deadline for some transitional devices has been extended. These devices have until 1 July 2029.

This gives time to get MDR certification before the end of the EU MDR transition on 31 December 2028. It also allows sponsors time to use the MDR certificate to apply to the TGA.

The transition does not apply to new applications for devices ineligible for transition. These must be lodged at the higher classification and approved before supply.

This came into place 25 November 2021. It has not changed.
 

Patient-matched medical devices

The transition notification period for patient-matched medical devices (PMMDs) ended on 1 November 2024.

All PMMDs will continue to be exempt from ARTG inclusion until 1 July 2029. They can be manufactured and/or supplied until this date, regardless of whether a notification was made prior to 1 November 2024.

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).

There will continue to be a 'low volume' exemption for PMMDs. As a result, the first five of a kind supplied in a financial year by one entity will not require an ARTG inclusion.

Exempt devices are exempt from inclusion in the ARTG. They are not exempt from regulation. Manufacturers and sponsors of exempt medical devices still need to meet the Essential Principles and advertising requirements.

Software 

The transition arrangement for the reclassification of software based medical devices ended 1 November 2024. 

However, some software-based medical devices may also be subject to other reclassification reforms. 

The medical devices listed in the table below have until 1 July 2029 to meet the requirements for those reforms.
 

Unique Device Identifier (UDI)

We are considering the impact on the Australian implementation of the Unique Device Identifier (UDI). 

More information

• EU MDR Transition
• Medical devices reforms