PV Bulletin

End of Windows 10 Support and Its Impact on Medical Devices

Some medical devices may be affected by the end of support for Microsoft Windows 10, raising cybersecurity concerns.

Primary source: Safety monitoring and information

PV Impact Brief

Urgency: HighConfidence: high

What changed

Manufacturers and sponsors are now required to develop a transition timeline to ensure continued security and compliance, including notifying customers if hardware upgrades for Windows 11 are needed.

Why it matters

The end of support could expose devices to cyber incidents, jeopardizing patient data and device functionality, thus necessitating immediate action from manufacturers to safeguard users.

Action needed

Companies must implement a strategy to upgrade from Windows 10 to Windows 11 and ensure compliance with essential safety principles, including notifying customers about potential vulnerabilities.

Relevant for
Medical Safety Lead
Processes impacted
Signal ManagementVendor Oversight
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Aug 17, 2026

Full briefing

Practical implication

Companies must implement a strategy to upgrade from Windows 10 to Windows 11 and ensure compliance with essential safety principles, including notifying customers about potential vulnerabilities.

With the cessation of support for Microsoft Windows 10 on October 14, 2025, devices that have not upgraded to Windows 11 may face increased cybersecurity risks and lack of support, necessitating a transition plan for manufacturers.

What changed: Manufacturers and sponsors are now required to develop a transition timeline to ensure continued security and compliance, including notifying customers if hardware upgrades for Windows 11 are needed.

Why it matters: The end of support could expose devices to cyber incidents, jeopardizing patient data and device functionality, thus necessitating immediate action from manufacturers to safeguard users.

Practical implication: Companies must implement a strategy to upgrade from Windows 10 to Windows 11 and ensure compliance with essential safety principles, including notifying customers about potential vulnerabilities.

View original source

  • Source: TGA Safety Alerts - News feed
  • Published at source: 2026-08-17T22:18:00.000Z
  • Discovered by monitor: 2026-08-17T22:20:48.220Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Device Vigilance#Australia#Source-ingestion#Regulator-monitor#Tga.gov.au

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