PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is pushing back implementation dates for numerous medical device reforms due to delays caused by the COVID-19 pandemic.
The delay would also support additional time for the TGA to consult with the device industry stakeholders on guidance material relating to the reforms, the TGA said.
As the EU's Medical Device Regulation (MDR) gets closer to being implemented, Australia will be implementing many of these regulations into its country's framework. Although the aim is to more closely align Australia with the EU MDR, certain terminology in Australian legislation and regulations has established meanings that may not be equivalent to those defined in EU regulations, and in these instances, Australia would keep to its own definitions.
The move comes after many years of consultations on revamping Australia's drug and device regulations. The TGA implemented its first tranche of new regulations in 2017, which required changes to the legislation.
Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) were to fall under new classification requirements on Aug. 25, 2020, and with the delay, manufacturers will now have until Nov. 25, 2021.
Those six classes of medical devices include:
- Spinal implantable medical devices (some will move from class IIb to class III);
- active implantable medical devices (from AIMD to class III);
- medical devices that administer medicines or biologicals by inhalation (from class I or class IIa to class IIa or class IIb);
- medical devices that are substances (or combinations of substances) for introduction into the body (from class I or IIa to class III)
- active medical devices for therapy that include a diagnostic function to significantly determine patient management (from class IIa or IIb to class III), and
- medical devices that are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system (from class IIa to class III).
The change in device classification means that sponsors will need to undergo conformity assessment procedures for their devices.
Many stakeholders had asked the TGA to wait until the EU released its final guidance on EU MDR classification rules, and these changes will be more in line with changes in the EU.
Delays to medical device software and personalized medical devices
Manufacturers of medical device software and personalized medical devices (including 3D-printed devices) will now have until Feb. 25, 2021, to comply with new regulations.
Industry was supportive of most of the changes proposed by the TGA for custom-made and 3D-printed devices. However, comments indicated that the current regulatory requirements for custom-made devices are not well understood.
The agency stressed that increasing use of 3D printing for medical applications is raising questions about the adequacy of the current medical device regulatory framework to mitigate risks to patients.
For example, 3D-printed implants or surgical tools that are made for a specific patient fit the Australian definition for custom-made devices and are exempt from being included in the Australian Register of Therapeutic Goods. They still must meet the requirements under the conformity assessment procedures for custom-made medical devices, but there is no requirement for third-party or regulatory certification of the manufacturer.
These exempt provisions were based on the idea that custom devices would largely comprise low-risk products, such as glass eyes, prosthetic limbs and prescription lenses. However, regulators now are faced with a different environment such that technology has made personalized devices available on a much greater scale.
Under the new regulations, the TGA is introducing new definitions for personalized devices under three categories (custom-made, patient-matched and adaptable), together with associated regulatory controls applied commensurate with the risks in each category.
The regulations establish a new medical device production system (MDPS) to enable health care professionals to safely produce personalized devices – often at point of care – using a certified turnkey system. Use of a certified system would mean that health care professionals producing these types of medical devices would not then be required to obtain manufacturer certification.
SaMD to follow EU model
TGA regulation of software as a medical device will also follow the EU MDR model. The TGA opened the consultation period in February 2019, noting that the scope of the draft was for software as a medical device (SaMD), while software in a medical device is regulated as part of that parent hardware device.
The agency said that the transition period for any final regulation would align with the EU MDR roll-out, which formally goes into force in May 2021.
New essential principles
The TGA had sought feedback in September 2019 on a proposal to change Australia's medical device essential principles for safety and performance to more closely mirror the new EU MDR.
Since Australia's market is only about 2% of the global market, "it makes much more sense to align regulations with a larger market for regulatory submissions," said TGA Health Products Regulation Group Deputy Secretary John Skerritt.
The essential principles defined in Australia's Therapeutic Good Act 1989 and the Therapeutic Good Regulations 2002 provide safety and performance requirements for device design and production, and manufacturers must have evidence that demonstrates compliance of their devices with these principles.
Most respondents agreed with the proposals to incorporate new requirements and provide greater clarity, and some requested further consultations regarding the details of the proposed changes. Most comments opposed using definitions proposed by the International Medical Device Regulators Forum.
New regs on device systems, procedure packs
The TGA said that new definitions for medical device systems and procedure packs will now go into effect on Nov. 25, 2021.
A system or procedure pack (SOPP) is a package containing therapeutic goods in which at least one component is a medical device or IVD. The products are packaged together either in combination or for use in a surgical procedure.
In Australia's device regulations, the terms "system" and "procedure pack" were not defined separately and were used interchangeably. New amendments introduce the definition of system, procedure pack and compatibility.
Under those definitions, a procedure pack is a combination of products at least one of which is a medical device or IVD packaged together and placed on the market with the purpose of being used in a medical procedure.
A system would be defined as a combination of products, either packaged together or not, which are intended to be interconnected, combined or used together to achieve a specific medical purpose.
Compatibility is defined as the ability of a device, including software, when used together with one or more devices according to its intended purpose to perform without losing or compromising the ability to perform as intended.