THE RISING IMPORTANCE OF CYBERSECURITY IN IVD ANALYZER DEVELOPMENT: Aligning with IVDR and FDA Guidelines

As in vitro diagnostic (IVD) devices become increasingly software-driven and connected, the risk landscape is evolving rapidly. No longer is performance or accuracy alone enough — cybersecurity has become a core component of both regulatory compliance and patient safety.

IVD Analyzers: High-Tech, High-Risk

Modern IVD analyzers often connect to hospital networks, cloud platforms, and other digital infrastructures. While this connectivity improves efficiency and data accessibility, it also creates potential entry points for cyberattacks — threats that could jeopardize both patient data and diagnostic integrity.

P780 Integrating Security from Day One

For P780 developers, cybersecurity could no longer be an afterthought. It had to be integrated from the earliest design phases, with cross-functional collaboration between software engineers, cybersecurity experts, regulatory teams, and quality assurance.

European and American requirements in a nutshell:

IVDR: Raising the Bar on Security

The European In Vitro Diagnostic Regulation (IVDR 2017/746) mandates that manufacturers perform comprehensive risk management, including cybersecurity threats. Annex I explicitly requires that devices be designed to minimize risks related to unauthorized access, data tampering, and software vulnerabilities.

Manufacturers must:

• Conduct cybersecurity risk assessments as part of their overall risk management file.
• Demonstrate proactive design controls to mitigate cybersecurity risks.
• Maintain post-market surveillance to respond to emerging threats.

FDA: Security Is Safety

In the U.S., the FDA’s premarket guidance on cybersecurity (most recently updated in 2023) emphasizes that cybersecurity is an integral part of device safety and effectiveness.

Key FDA expectations for IVD devices include:

• A Software Bill of Materials (SBOM) to improve transparency.
• Threat modeling to identify potential vulnerabilities early.
• Design features like authentication, data encryption, and update mechanisms.
• A cybersecurity management plan covering the entire product lifecycle.

By aligning with IVDR and FDA cybersecurity expectations, Diatron not only meets regulatory requirements but also builds trust with healthcare providers and patients — and better prepare for a resilient, secure digital future.