Windows 10 end of support and its potential impact on medical devices

Windows 10 support ended on 14 October 2025. This means some medical devices that haven’t upgraded to Windows 11 may be at risk of cyber incidents. It is crucial for impacted medical devices to have a plan for continued security. 

The October 2025 security updates are the last available for Windows 10. Affected organisations are encouraged to review Microsoft’s news item and October 2025 Security Update guide for full details.

For consumers

If you use a device and are unsure if it currently uses Windows 10, contact the sponsor, supplier, or place of purchase to discuss the options for support.

For manufacturers and sponsors

Devices relying on Windows 10 will no longer be supported and may be vulnerable to unauthorised users or malicious actors. 

Users can only maintain support through the Windows 10 Consumer Extended Security Updates (ESU) program. An ESU to support Windows 10 is slated to continue until 10 October 2028. Manufacturers and sponsors should consider a transition timeline to maintain Windows 10 ESU support and eventually upgrade all systems to Windows 11 where feasible.

Manufacturers and sponsors are required to ensure, and notify customers, if their existing hardware requirements are insufficient for a Windows 11 upgrade and provide an alternative solution. Any operating system upgrade must maintain compliance with the Essential Principles to protect patient data and ensure device functionality. 

Any new devices supplied, that use the Windows operating system, should be supplied with Windows 11 or Windows 10 with the ESU and a transition plan in place. 

Key information for sponsors and manufacturers

1. Complying with medical device cyber security requirements

Guidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.

2. Understanding your post-market responsibilities for medical devices

Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.

3. Procedure for recalls, product alerts and product corrections (PRAC)

Market actions may be required, such as a product alert to inform users of the risks associated with devices that continue to use Windows 10, or a product correction to inform users of any changes, including upgrading to Windows 11, due to safety risks.

Reporting problems

We strongly encourage consumers and health professionals to report problems with medical devices. These reports will contribute to the TGA's monitoring of these products. See the TGA Incident Report and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition or treatment. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

If you have concerns about a product’s compliance with TGA’s requirements, you can report these concerns using the Report a perceived breach or questionable practices form.