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    What's new in MedTech cyber

    Short, dated updates on FDA enforcement, EU MDR/MDCG guidance, standards revisions, and notable vulnerabilities.

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    1. FDAUpdated · 3d ago

      Mid-2026 field notes: what's tripping up 524B submissions right now

      Five months into the Feb 3, 2026 guidance, a clear pattern of deficiencies has emerged around SBOM depth, VEX handling, and AI/ML threat modeling. Here's what reviewers are flagging most this quarter.

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    2. StandardsUpdated · 13d ago

      HHS 405(d) HICP 2026 refresh: what changes for MedTech manufacturers

      The Health Industry Cybersecurity Practices (HICP) 2026 refresh from HHS 405(d) tightens the manufacturer-facing sections, especially around SBOM disclosure to HDOs and coordinated vulnerability handling.

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    3. FDAUpdated · 1mo ago

      PCCPs and cybersecurity: what changes when your AI model updates itself

      FDA's Predetermined Change Control Plans let AI/ML devices ship updates without a new submission - but the cyber risk surface moves with every retrain. Here's how to scope a PCCP that doesn't quietly invalidate your 524B package.

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    4. EU MDRUpdated · 3mo ago

      MDCG 2019-16 Rev.2 lands - Notified Body audits are catching up

      The latest revision to MDCG 2019-16 tightens expectations around SBOMs, post-market vulnerability handling, and traceability between security risk controls and design outputs. Here's the FDA-to-CE gap, condensed.

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    5. FDAUpdated · 5mo ago

      FDA issues updated premarket cybersecurity guidance (Feb 3, 2026)

      The FDA's Feb 3, 2026 revision to 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions' is now the current final guidance. Here's what changed versus the 2023 edition and what to update in your submission templates.

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    6. FDAUpdated · 5mo ago

      QMSR replaces 21 CFR 820 - what changes for cybersecurity

      FDA's Quality Management System Regulation harmonizes Part 820 with ISO 13485. Cyber design controls and CAPA expectations carry over with subtle scoping changes.

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    7. FDAUpdated · 9mo ago

      Two years of Section 524B: what FDA reviewers are pushing back on

      Patterns from recent deficiency letters: weak SBOM hygiene, missing VEX statements, and CVD policies that exist on paper but have no real intake.

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    8. EU MDRUpdated · 11mo ago

      MDCG 2019-16 Rev.2 expectations carry into Notified Body audits

      European Notified Bodies are now expecting evidence of IEC 81001-5-1 alignment, not just MDCG 2019-16 narrative.

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    9. SiteUpdated · 1y ago

      MedTechCyberTips.com is live

      Nine deeply organized topics, a guided journey, and a glossary covering every acronym in FDA cyber guidance.

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