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MDCG (EU) medical device cybersecurity updates

MDCG (EU)

Regulatory tracker entries from MDCG (EU) that affect medical device cybersecurity submissions, postmarket programs, or supply-chain disclosures.

1 tracked changeLast reviewed Oct 22, 2026 RSS

Jul 1, 2025·GuidanceActiveHigh impact
MDCG 2019-16 Rev. 2: MDR/IVDR cybersecurity expectations
Revised MDCG cybersecurity guidance details security risk management, IT environment assumptions, and basic UDI/postmarket cybersecurity expectations for Notified Body review.
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EU Commission
FDA
HHS 405(d)
IEC
ISO/IEC
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MDCG 2019-16 Rev. 2: MDR/IVDR cybersecurity expectations

Other agencies in the tracker

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