Many Medical devices and Invitro Diagnostic (IVD) manufacturers gain market authorizations or device approvals in Australia using the conformity assessment certification issued by the EU Notified Bodies.

Below are the various factors affecting or impacting device registration in Australia.

Medical Device Regulations in Europe:

There were various grounds for making changes in the EU medical device regulations; most of the regulations were outdated, and there was no consistency as each country had its own regulations. There was no proper tracking of the post-market performance of the products, no precise clinical evidence requirements, no adequate scrutiny of Notified Bodies, and most of the IVDs were excluded from regulations that caused severe impacts on public health.

The main changes made in the EU medical devices and IVDs are as follows:

The Medical Device Directives (MDD 94/42/EEC), AIMD Directives (AIMDD 90/385/EEC) and IVD Directive (IVDD 98/79/EC) are replaced with New Medical device regulation (MDR 2017/745) and IVD regulations (IVDR 2017/746).

Major Changes in the EU Regulatory Framework:

The changes done to the EU Regulatory framework are as follows:

• Changes in the definitions like the addition of new definitions and modification of existing one
• Amendment to the scope
• Designation and governance of Notified Bodies, laboratories, and clinical panels
• Reclassification of various devices like spinal implants, AIMD (along with accessories), Active Medical Devices for therapy with diagnostic function, devices in direct contact with heart, CVS or CNS, devices that are used to administer medicines or biologicals by inhalation, body orifice, or skin, and software medical devices
• Packaging or labeling instructions and Unique Device Identification (UDI)
• Creation of EUDAMED database for all the devices to monitor the pre-market and post-market data
• The EU is also making changes to clinical trials review requirements, essential principles, and conformity assessment methods.

Impact of the EU changes on the Australian Regulatory Framework

• There are specific changes made in the regulation of Software as Medical Devices (SaMD) like reclassification of SaMD, exemption of specific clinical decision software, etc.
• Development of a new Regulatory framework for the personalized medical devices (including custom made medical devices)
• The IVD medical devices regulation in Australia are in alignment with the new EU system in terms of independent certifications, new declaration of conformity, strong clinical evidence, PMS, and labeling changes, etc.
• 90% of the registration of medical devices in Australia is based on CE certification or third-party certification and the EU wants to recertify all these devices as per the MDR by May 2024, to which Australia is aligning with this flow and is accepting evidence from a wider range of countries to support listing or inclusion process
• TGA is aligning with the EU requirements for the designation of conformity assessment Notified Bodies and the Agency will accept the applications of Australian companies from July
• TGA cannot issue CA certifications as the current mutual recognition agreement is not as per the new EU regulations
• Apart from the above changes, there are various other changes like priority review of certain novel devices and low-risk devices, UDIs, increased post-market procedures, reclassification of surgical meshes and other devices and patient material like implant cards and information leaflets, etc.

Impact of Delay in the EU MDR Transition Due to COVID-19 on the Australian Regulatory Framework

Lack of detailed information on the EU Regulatory changes, the developing MDR guidance, and other challenges are making it complicated to make the reforms in the TGA, which can be cleared with the implementation of MDR. Are you willing to register your devices in the Australian market? Do you need an expert’s assistance in implementing the Australian Regulatory framework?  Stay informed. Stay compliant.