Enhanced Cybersecurity for Medical Devices: Protecting Against Cyber Threats
New regulations aim to boost the security of medical devices that connect to the internet or contain software. Manufacturers will be required to protect these devices from threats throughout their lifespan, ensuring the safety and effectiveness of these technologies.
Key points
Medical device manufacturers must submit plans for monitoring and addressing cybersecurity vulnerabilities.
Requirement to make available software updates and patches to address known vulnerabilities.
Medical devices lacking adequate cybersecurity information may be found substantially inequivalent, potentially affecting their approval.
Status:
Expired
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