What’s going on with Medical Devices Down Under?

So what’s going on with Medical Devices Down Under? We’ve got Brexit’s repercussions to consider and of course the dates of application for the EU Medical Devices Regulations (MDR) 2017/745 and In Vitro Diagnostics Medical Devices (IVDR) 2017/746 are fast approaching too. It’s easy when we are caught up with major changes at home, to overlook regulatory changes occurring in other territories. In Australia, there have been a number of changes to medical device regulations in recent months, which may have bypassed you. Luckily, Regulation is what we do, so IMed can give you the highlights, to save you having to trawl through all the regulatory news, just on the off-chance of finding something you might need to know about.

Australia – Medical Device Regulatory news;

Changes to Software-Based Medical Devices

Were you aware that reforms to the regulation of software-based medical devices were implemented on 25 February 2021?

Manufacturers of such devices need to be aware of these changes. There is a transition period for devices already included in the Australian Register of Therapeutic Goods (ARTG), which ends 1 November 2024, as long as you notify the TGA before 25 August 2021. But if you are intending to submit an application for the inclusion of software-based medical devices in the ARTG, you will need to meet the new requirements.

Changes to Custom-Made Medical Devices

Furthermore, on 25 February 2021, a new regulatory framework was introduced to describe Personalised Medical Devices (PMD), which include the following:

• Custom-made medical device
• Patient-matched medical device
• Devices produced using a Medical Device Production System
• Adaptable medical device

This means that the definition of a custom-made medical device has changed to exclude devices which meet the new definitions of patient matched medical device or an adaptable medical device. The manufacturers of such devices should review the new definitions, as their devices may now require inclusion in the ARTG or be required to meet new conditions of the exemption.

Future Reforms

On 25 November 2021, implementation of the reform for reclassification of certain devices is due to be implemented. This is to reclassify a number of medical devices so that they align (where possible) with the changes made to the EU regulations. The devices include:

• spinal implantable medical devices
• active implantable medical devices
• medical devices that administer medicines or biologicals by inhalation
• medical devices that are substances (or combinations of substances) for introduction into the body
• active medical devices for therapy that include a diagnostic function to significantly determine patient management, and
• medical devices that are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system

It is currently suggested that implementation of the amended ‘essential principles’ within the Australian Medical Device Regulations, will be delayed for up to two years after the date of application of the EU MDR. With a similar delay of two years applied to the essential principles for In Vitro Diagnostics.

And finally, there are a couple of prior changes, which should also be noted;

• On 25 August 2020, the definition of a medical device and some other definitions including ‘system or procedure packs’, have been altered or introduced within the Therapeutic Goods Act 1989.
• Also; minor updates were made to the regulatory requirements relating to system or procedure packs, with notice that further changes will occur at a future date.

Further information can be found on the TGA’s handy Medical Device Reforms page or by reaching out to IMed Consultancy. Why not sign up for our newsletter to make sure that you are kept well informed on any important UK, EU and Global Regulatory news.