On 25 April 2024, the European Union (EU) further extended the EU IVDR transition periods for IVD medical devices.
If eligibility conditions are met, the EU extension applies to the following IVD medical devices:
- devices covered by a valid certificate issued by a Notified Body under the In Vitro Diagnostic Directive 98/79/EC (IVDD) before 26 May 2022
- devices for which the manufacturer made a declaration of conformity under the IVDD before 26 May 2022.
IVDD Notified Bodies will continue to be responsible for ongoing oversight of manufacturers they have certified, until the manufacturer transitions to an IVDR Notified Body.
Our revised strategy
Key elements of our EU MDR transition strategy have not changed:
- Reduced application fees to supply devices with non-compliant labelling
- Reduced application fees to update the conformity evidence to EU IVDR certification.
New applications
If the sponsor provides evidence that the manufacturer meets the EU extension conditions, we will consider certificates issued by Notified Bodies under the IVDD that were valid on 26 May 2022 and accept the manufacturer's declaration of conformity under the EU IVDD made before 26 May 2022, to be valid until:
- 31 December 2027 for Class 4 IVDs
- 31 December 2028 for Class 3 IVDs
- 31 December 2029 for Class 2 IVDs.
The EU extension conditions include:
- there are no significant changes in the design or intended purpose of the devices
- the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health
- before 26 May 2025, the manufacturer puts in place a quality management system compliant with the EU IVDR
- for devices requiring a Notified Body assessment, the manufacturer applies to an IVDR Notified Body to certify the device by 26 May 2025 (class 4 IVDs), 26 May 2026 (class 3 IVDs), or 26 May 2027 (class 2 IVDs)
- the manufacturer and an IVDR Notified Body both sign a written agreement to proceed with conformity assessment under the EU IVDR by 26 September 2025 (class 4 IVDs), 26 September 2026 (class 3 IVDs), or 26 September 2027 (class 2 IVDs).
We will accept the following evidence, as applicable:
- A manufacturer's self-declaration that they meet the EU extension conditions
- A signed agreement between the manufacturer and the EU IVDR Notified Body for conformity assessment under the EU IVDR for the device
- A document issued by an EU IVDR Notified Body stating the manufacturer applied for conformity assessment under the EU IVDR for the device
- Evidence that an EU national competent authority:
(a) granted the manufacturer a derogation from the applicable conformity assessment procedure in accordance with Article 54 of the EU IVDR, or
(b) required the manufacturer to carry out the conformity assessment procedure within a specific time in accordance with Article 92 of the EU IVDR.
Note that we may undertake post-market sampling and request evidence from the manufacturer, and criminal (and civil) penalties of up to 5 years imprisonment may apply for making a false or misleading statement.
Existing ARTG entries
Many existing ARTG entries are supported by EU IVDD evidence. We will consider certificates that qualify for extended validity in the EU to be in-force in Australia and not ‘expired’, despite the expiry date listed on the certificate. However, we will not consider IVDD evidence to be in-force after:
- 31 December 2027 for Class 4 IVDs
- 31 December 2028 for Class 3 IVDs
- 31 December 2029 for Class 2 IVDs.
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 IVDD certificate. However, sponsors must provide the TGA with evidence of the extended validity of the certificate if requested.
Sponsors must notify us within 60 days of becoming aware of any IVDD 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. We will consider compliance case-by-case and may cancel or suspend an ARTG entry that no longer has conformity assessment certification.
More information
Transitioning to new manufacturer evidence for in-vitro diagnostic medical devices (IVDs)