Medical Device Reforms – Navigating the Impact of EU Reforms on the Reclassification of select Medical Devices in Australia
Recognising the impact of the European Union (EU) reforms from the overhaul of medical device directives (MDD) and in vitro device directives (IVD) to regulations (MDR/IVDR), Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) have proactively engaged in public consultations to align Australian medical device regulations with the new EU framework.
Consultations commenced in early 2019 for the medical devices impacted, with stakeholder response overwhelmingly supporting the alignment of the Australian regulations with the EU MDR/IVDR. Subsequently, in December 2019, the TGA enacted the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations, triggering the reclassification of six categories of medical devices to align with the new EU framework.
Reclassification Overview
Effective from 25th November 2021, the re-classification of some medical devices came into effect, with sponsors of affected existing registered products1 mandated to notify the TGA of their devices to be re-classified by 25th May 2022. The re-classified medical devices are outlined in the table below.
| Medical device type | Pre-25 Nov 2021 Classification | Revised Classification |
|---|---|---|
| Active medical devices for therapy with diagnostic function | IIa or IIb | III |
| Spinal implantable medical devices (motion preserving) | IIb | III |
| Devices used in direct contact with the heart, central circulatory system (CCS), or central nervous system | IIa | III |
| Medical devices that administer medicines or biologicals by inhalation | I or IIa | IIa or IIb |
| Medical devices that are substances introduced into the body via body orifice or applied to the skin | I or IIa | IIa, IIb or III |
| Active implantable medical devices (AIMD) | AIMD | III |
The original deadline to re-classify was by 1 November 2024.
EU Medical Device Reforms Extensions
In February 2023, the EU extended their transition dates from 26 May 2024 to:
- 31 December 2027, for Class III medical devices and for Class IIb implantable medical devices.
- 31 December 2028, for Class IIb medical devices and for Class IIa and Class I medical devices that are supplied in a sterile state and Class I medical devices with a measuring function.
Given that numerous ARTGs rely on European certification, it is highly unlikely for manufacturers of the listed devices in the table above to secure recertification by the initial deadline of 1 November 2024, particularly for products transitioning from Class I to Class III.
TGA Extensions
The TGA convened in March 2023 to propose extending the transition deadlines for the medical device reclassification reforms. This was recently enacted in November 2023, extending the deadline from 1 November 2024 to 1 July 2029, providing manufacturers and sponsors an additional five years to re-classify.
The only exception to the extension was AIMDs which remain with a deadline of 1 Nov 2024.
No extension was given to the notification period, therefore new devices (as listed in the above table) entering the ARTG must do so under the revised classification.
How can PharmOut Help?
PharmOut can help you with Medical Device Registration with the TGA in Australia, providing regulatory compliance services for medical device product classification, preparation of technical files, and troubleshooting compliance problems.
Explanatory Note
1 Registered products are those with entries on the Australian Register of Therapeutic Goods (ARTG).
