Regulatory tracker · agency

EU Commission medical device cybersecurity updates

EU Commission

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

1 tracked changeLast reviewed Oct 22, 2026 RSS

Dec 11, 2027·Regulation (applies)ScheduledHigh impact
EU Cyber Resilience Act becomes fully applicable
The CRA's core obligations - secure-by-design, SBOM, vulnerability handling, and 24-hour incident reporting - apply to products with digital elements placed on the EU market. Devices regulated under the MDR or IVDR are excluded.
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Other agencies in the tracker

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

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EU Cyber Resilience Act becomes fully applicable

Other agencies in the tracker

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