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.
- 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 2020 or May 2022, respectively.
- The new regulations will be fully applicable in May 2020 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.
TGA is also aware that some notified bodies have indicated that they do not intend to transition to the new MDR (eg Lloyds Register, QS Zürich AG) and that they are in the process of assisting their clients to transfer to another notified body.
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. This may impact manufacturers seeking certification for new products, and may also have impacts for maintaining existing certification, particularly where European notified choose not to transition to the new regulations.
The TGA is monitoring the situation and if there are any 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.