Medical Device Cybersecurity
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Medical device cybersecurity is the design, documentation, and lifecycle management of a device’s resistance to unauthorized access, tampering, and exploitation that could compromise safety or data. Regulators now treat cybersecurity as a patient-safety issue integral to device design, not an IT afterthought, and require it addressed from premarket design through post-market vulnerability management.
Premarket expectations include threat modeling, a secure development lifecycle, a software bill of materials, and evidence of security testing; post-market expectations include monitoring for vulnerabilities, coordinated disclosure, and the ability to deliver patches/updates safely over the device’s supported life.
In the US, the FD&C Act was amended (section 524B) to give FDA explicit authority to require cybersecurity information for "cyber devices," making an SBOM and a plan to monitor and address vulnerabilities part of premarket submissions. The EU addresses the same concerns through MDR general safety and performance requirements.
- —Cybersecurity treated as a patient-safety design attribute.
- —Premarket: threat modeling, secure SDLC, SBOM, security testing.
- —Post-market: vulnerability monitoring, coordinated disclosure, patching.
- —US authority via FD&C Act §524B (cyber devices).
FDA premarket cybersecurity guidance and FD&C Act §524B (added by the Consolidated Appropriations Act, 2023); EU MDR 2017/745 Annex I §17.2 general safety and performance requirements.
Frequently asked questions
What is Medical Device Cybersecurity?
Medical device cybersecurity is the design, documentation, and lifecycle management of a device’s resistance to unauthorized access, tampering, and exploitation that could compromise safety or data. Regulators now treat cybersecurity as a patient-safety issue integral to device design, not an IT afterthought, and require it addressed from premarket design through post-market vulnerability management.
Which regulations cover Medical Device Cybersecurity?
FDA premarket cybersecurity guidance and FD&C Act §524B (added by the Consolidated Appropriations Act, 2023); EU MDR 2017/745 Annex I §17.2 general safety and performance requirements.