EU MDR transition provisions affecting ARTG inclusions of non-IVD medical devices – June 2023
Last month, the Australian Therapeutic Goods Administration (TGA) announced that the transition from certification to the old EU Directives for medical devices, including active implantables, to the new EU Medical Devices Regulation (MDR) as basis for inclusion in the ARTG has been extended. This is good news for manufacturers, sponsors, and agents as it buys them more time to obtain CE Marking approvals for their non-IVD medical devices under the EU MDR and use them as basis for inclusion into the Australian Register of Therapeutic Goods (ARTG).
By Val Theisz
In March 2023, the European Commission published its decision to extend the EU MDR transition timelines to allow manufacturers to continue placing their medical devices on the market using their existing certificates issued under the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), and thus avoid shortages of medical devices in EU due to the slower than anticipated transition from the medical device Directives to MDR and IVDR.
Regulation (EU) 2023/607 of 15 March 2023 amending the MDR and IVDR stipulates that the validity of certificates issued under the MDD and AIMDD is to be extended, along with the transitional period during which devices that are in conformity with the MDD and AIMDD can lawfully be placed on the market, from 26 May 2024 to:
- 26 May 2026 for class III custom-made implantable 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.
Since the 2017 enactment of the EU MDR, the TGA has been updating the Australian medical device regulations to align with the more stringent provisions of the MDR, specifically:
- more stringent requirements to demonstrate medical device safety for patients and users including requirements for clinical evidence
- additional requirements for the manufacturer’s quality management systems
- detailed technical document requirements
- changes to classification rules for medical devices
The great majority of medical devices included in the ARTG rely on having a valid European Certificate of Conformity. A delay in obtaining a certificate under the MDR means that the TGA had to update its own transition timelines to avoid a supply shortage on the Australian market or avoid supplying medical devices in Australia without a valid certificate.
The following MDD certificates that have been extended in the EU, as new or revised Manufacturer Evidence, will now be accepted by the TGA:
- until 26 May 2024, MDD certificates that have not expired, recognising that the expiry date on MDD certificates will not be updated
- until 26 September 2024, 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, 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.
As the EU removed its 12-month “sell-off” provision, 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. Hence, the 12-month transition for Australian sponsors to supply devices manufactured before their EU MDD certificate expired, which mirrored the EU “sell-off” deadline, no longer applies.
In addition, the TGA clarified that:
- 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.
- 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 any MDD certificate that supports ARTG entries that is no longer valid in the EU, e.g., a certificate that is suspended, cancelled, withdrawn or does not meet the extension requirements in the EU.
The reclassification of certain medical devices in Australia came into effect on 25 November 2021, specifically for:
- active medical devices for therapy with diagnostic function,
- spinal implantable medical devices (motion preserving),
- devices used in direct contact with the heart, central circulatory system, or central nervous system,
- medical devices that administer medicines or biologicals by inhalation, and
- medical devices that are substances introduced into the body via body orifice or applied to the skin.
New applications for ARTG inclusion must be lodged at the higher classification.
Sponsors of existing ARTG entries who notified the TGA before 25 May 2022, must apply for their device to be included in the ARTG at the higher classification before 1 November 2024, failing which their ARTG entries at the lower classification will be cancelled.
The TGA stated on its website that “is considering the impact of the EU MDR transition extension on Australia’s reclassification and personalised medical device reforms and will provide advice to the Government about whether changes to the transition timeframes will be needed”.
Further details are available on TGA’s dedicated webpage EU MDR Transition.
