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MedTech Cybersecurity · Since 2022

ISO/IEC Medical Device Cybersecurity Updates

Regulatory tracker · agency

ISO/IEC medical device cybersecurity updates

ISO/IEC

Regulatory tracker entries from ISO/IEC that affect medical device cybersecurity submissions, postmarket programs, or supply-chain disclosures.

1 tracked changeLast reviewed Oct 5, 2026 RSS

Oct 31, 2025·Standard transitionActiveMedium impact
ISO/IEC 27001:2022 transition deadline passes
Organizations still certified to ISO/IEC 27001:2013 lost certification on 31 October 2025. Hospitals expect the 2022 control set (including A.8 secure development, A.5.7 threat intelligence) in procurement.
Read details

Other agencies in the tracker

AAMI
CISA
CycloneDX
EU Commission
FDA
HHS 405(d)
IEC
MDCG (EU)
NIST
Red Hat
SPDX (Linux Foundation)

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