European implementation of Medical Device and IVD Regulations - Implications for Australia
Update - 23 July 2020
The Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the challenges identified by the medical devices industry and healthcare professionals to redirect their efforts to regulatory changes as they have focussed on the COVID-19 crisis.
The delay will allow additional time for the Therapeutic Goods Administration (the TGA) to further consult with the medical device industry and health care professionals on guidance material and implementation details relating to the reforms.
For further information see: Delays to the commencement of certain medical device regulatory changes.
Many sponsors of medical devices and in vitro diagnostic (IVD) devices use manufacturer's conformity assessment certification issued by European notified bodies to support applications for marketing authorisation in Australia.
European Medical Device Regulations
New European regulations on medical devices (2017/745) (EU MD Regulations) and IVDs (2017/746) (EU IVD Regulations) entered into force from May 2017, with a three year transition period for new medical devices, and a five year transition period for IVDs.
In April 2020, the EU MD Regulations were amended to postpone the date that most provisions were set to commence by one year to 26 May 2021 (Regulation (EU) 2017/745 and Regulation (EU) 2020/561). The postponement of EU MD Regulations aims to take the pressure off national authorities, notified bodies, manufacturers and other sectors so they can focus fully on urgent priorities related to the COVID-19 pandemic.
- European notified bodies which undertake conformity assessment of medical device and/or IVD manufacturers need to be designated under the new MDR or IVDR by no later than May 2021 or May 2022, respectively.
- The new regulations will be fully applicable in May 2021 for medical devices and May 2022 for IVDs and new devices after this time will need to comply with the new EU regulations. Existing medical devices and IVDs will need to change to the new EU regulations as certification expires. The European Commission has outlined the transitional arrangements, and during this transitional period certification which remains valid in Europe may also be used as evidence in Australia.
We understand that manufacturers have been working with their European notified bodies about transitional arrangements applied to their products, and the continuity of their conformity assessment certification through this transition.
Implications for Australian supply
Often sponsors submit with their ARTG inclusion applications supported by certificates issued by a European notified body, and manufacturers need to maintain continuity of such certification while supply of the device continues.
The TGA is aware of industry concern should a sufficient number of notified bodies not have been designated under in the new EU MD Regulations by May 2020. The TGA is aware that the delay to the commencement of the EU MD Regulations may impact manufacturers seeking certification for new products, and may also have impacts for maintaining existing certification. The European Commission has allowed the temporary renewal of the designation of notified bodies where that expires in the period from 26 May 2020 to 25 May 2021. This will allow those notified bodies to continue to issue and renew certificates under the Medical Device Directives until 25 May 2021. The European Commission has also put into place temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions. The measures being employed may differ depending on the circumstances. Specific advice should be sought from the notified body that issued the certificate.
In response, the Governor-General in Council has made regulations which also delay the commencement of a number of medical device reforms that are aligned with EU MD Regulations. This delay will provide manufacturers with an additional six months after the EU MD Regulations commence in May 2021 (until November 2021) to leverage certificates granted overseas and minimise the disruption and potential regulatory burdens.
The TGA is monitoring the situation and if there are any further significant changes to the current EU transitional arrangements prescribed in the EU MD Regulation or EU IVD Regulation, we will consider whether any flow on amendments may be required in Australia.
Alternative comparable overseas regulator approvals
In addition, in 2018 TGA implemented a significant reform that broadens options for sponsors to demonstrate compliance of their devices with the Australian requirements. These comparable overseas regulator arrangements may provide alternative pathways if delays arise in obtaining or maintaining European conformity assessment evidence.
Specifically the manufacturers' conformity assessment documents acceptable for both pre-market authorisation and post-market compliance now include:
- European certification: TGA will continue accepting valid EC Certificates issued in accordance with any of the Directives (medical devices, Active Implantable Medical Devices and IVDs) until their expiry date or May 2024, whichever is the earliest.
- Other comparable Overseas Regulatory approvals: TGA accepts appropriate approvals from the US FDA, Health Canada and Japan MHLW/PMDA, and certificates issued under the Medical Device Single Audit Program (MDSAP). These documents provide alternate pathways to support ARTG inclusion applications, and are defined by the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.
- TGA Conformity assessment certificate: Manufacturers may seek conformity assessment certificate for medical device and IVD from the TGA.