https://medtechcybertips.com/updates FDA, EU MDR, and standards updates affecting medical device cybersecurity. en-us Sat, 11 Jul 2026 00:52:44 GMT https://medtechcybertips.com/updates/mid-2026-deficiency-patterns https://medtechcybertips.com/updates/mid-2026-deficiency-patterns Wed, 08 Jul 2026 00:00:00 GMT FDA 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. https://medtechcybertips.com/updates/hhs-405d-hicp-2026-refresh https://medtechcybertips.com/updates/hhs-405d-hicp-2026-refresh Sun, 28 Jun 2026 00:00:00 GMT Standards 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. https://medtechcybertips.com/updates/pccp-cyber-intersection-2026 https://medtechcybertips.com/updates/pccp-cyber-intersection-2026 Wed, 10 Jun 2026 00:00:00 GMT FDA 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. https://medtechcybertips.com/updates/mdcg-2019-16-rev2 https://medtechcybertips.com/updates/mdcg-2019-16-rev2 Sat, 18 Apr 2026 00:00:00 GMT EU MDR 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. https://medtechcybertips.com/updates/fda-premarket-cyber-guidance-feb-2026 https://medtechcybertips.com/updates/fda-premarket-cyber-guidance-feb-2026 Tue, 03 Feb 2026 00:00:00 GMT FDA 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. https://medtechcybertips.com/updates/qmsr-takes-effect https://medtechcybertips.com/updates/qmsr-takes-effect Mon, 02 Feb 2026 00:00:00 GMT FDA FDA's Quality Management System Regulation harmonizes Part 820 with ISO 13485. Cyber design controls and CAPA expectations carry over with subtle scoping changes. https://medtechcybertips.com/updates/524b-two-year-checkin https://medtechcybertips.com/updates/524b-two-year-checkin Wed, 15 Oct 2025 00:00:00 GMT FDA Patterns from recent deficiency letters: weak SBOM hygiene, missing VEX statements, and CVD policies that exist on paper but have no real intake. https://medtechcybertips.com/updates/eu-mdr-cyber-annex-update https://medtechcybertips.com/updates/eu-mdr-cyber-annex-update Wed, 20 Aug 2025 00:00:00 GMT EU MDR European Notified Bodies are now expecting evidence of IEC 81001-5-1 alignment, not just MDCG 2019-16 narrative. https://medtechcybertips.com/updates/site-launch https://medtechcybertips.com/updates/site-launch Sun, 01 Jun 2025 00:00:00 GMT Site Nine deeply organized topics, a guided journey, and a glossary covering every acronym in FDA cyber guidance.