Cyber Security Guidance for Legacy Devices

IMDRF] Draft Guidance on Cyber Security for Legacy Devices

IMDRF will issue a draft guidance on cybersecurity of legacy devices on May 4, 2022, entitled “Principles and Practices for the Cybersecurity of Legacy Medical Devices” was issued.

This guidance was developed in response to comments that the cybersecurity guidance issued in 2020 does not adequately address legacy devices.

This guidance lists the various stages of TPLC for legacy devices, from development to end of support.
It then outlines how manufacturers and healthcare providers can communicate to ensure that they understand each other’s responsibilities at all stages of the process.

This Draft Guidance is open for feedback from interested parties until July 3, 2022.
Final draft guidance will then be issued as early as next spring.

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