Why Embedded Cybersecurity is Now Critical for EU MedTech Software Vendors?

On June 3, 2024, Synnovis, a pathology services provider for several NHS Trusts in southeast London, fell victim to a ransomware attack by the Qilin cybercriminal group.

This breach disrupted critical diagnostic services which led to the postponement of over 800 operations and 700 outpatient appointments. The attackers also exfiltrated and published sensitive patient data.

This incident underscores the urgent need for robust cybersecurity measures in the MedTech industry.

Embedded Cybersecurity is Now a Core Compliance Requirement

MedTech software now operates in a space where cybersecurity is tightly linked to patient safety.

With regulations like EU MDR, IVDR, NIS2, and GPSR, security is now treated as a formal requirement for product safety and compliance.

For EU market access, software vendors must now prove that their device software has been developed using secure-by-design principles, with safeguards in place right from architecture through post-market updates.

The new GPSR also brings a broader definition of “unsafe product,” where a security vulnerability alone can lead to a recall.

Every Layer of the Software Stack is a Security Responsibility

Today’s embedded systems run a mix of in-house firmware, open-source libraries, vendor SDKs, and device drivers.

Each layer – from bootloader to middleware to application – forms a potential attack surface. Regulators now expect software vendors to maintain full visibility and traceability across all these components.

Under NIS2, the responsibility for supply chain security includes not just third-party vendors, but also every software dependency, even niche drivers and legacy libraries. This means vendors must manage a Software Bill of Materials (SBOM) and address vulnerabilities across their entire stack proactively.

Security lapses in low-level code can now trigger top-level compliance consequences.

EU Cyber Regulations Now Start at Code-Level Design

The MDR and IVDR now demand that software safety includes protection from unauthorized access, data leaks, and system compromise. That means encryption, secure boot, access control, session timeouts, and real-time audit logs must be designed into the software.

The NIS2 directive, coming into effect across all EU member states by October 2024, adds additional requirements:

➡️ Incident reporting within 24 to 72 hours

➡️ Continuous risk monitoring

➡️ Personal liability for senior management

And GPSR, effective December 2024, means a software flaw can now legally render a product “unsafe.” This can lead to recalls, market withdrawal, or blocked CE marking.

Legacy Code in the Field Creates Long-Term Exposure

Many MedTech devices are designed to operate in the field for 10-30 years. Older devices may be running firmware written a decade ago, often in C/C++, without modern memory protection. Without over-the-air update capabilities, patching vulnerabilities becomes complex, expensive, and time-intensive.

These legacy devices often carry technical debt that grows over time. Each new vulnerability disclosed globally can impact code written years ago. Yet replacing or rewriting that software is rarely feasible at scale.

This ongoing exposure means embedded vendors need security solutions that protect both new and legacy deployments, without requiring requalification or full code rewrites.

Embedded Cybersecurity Brings Engineering-Specific Constraints

Unlike IT systems, embedded medical devices have limited memory, compute, and energy. Applying standard enterprise security tools often results in degraded performance or device malfunction.

Embedded devices must maintain real-time behavior, which rules out many resource-heavy protections. In regulated contexts, even minor updates to security components may require full revalidation under MDR.

Embedded security requires precision – lightweight encryption, isolated components, secure memory handling, and low-latency runtime protection, tailored to constrained systems.

A Strong Cybersecurity Posture is Now a Market Differentiator

Across Europe, MedTech buyers, from hospitals to clinical labs, now request security documentation like penetration test reports, SBOMs, and incident response policies during procurement.

Distributors are also evaluating vendors’ cybersecurity maturity to avoid downstream liability under NIS2.

Showing security compliance can accelerate regulatory approvals, improve contract negotiations, and serve as a signal of engineering discipline and product reliability.

Embedded Cybersecurity Begins with Embedded Software Thinking

The shift in regulation and threat landscape calls for embedded vendors to integrate cybersecurity across every phase:

✔️ Development: Secure bootloaders, stack protection, memory isolation

✔️ Testing: Penetration testing, fuzz testing, static analysis

✔️ Operations: Runtime anomaly detection, secure updates, patch pipelines

✔️ Lifecycle: SBOM tracking, post-market surveillance, EOL security plans

Security standards like ISO 14971, IEC 62443, and AAMI TIR57 guide how embedded software can be built and maintained in a way that aligns with both device safety and cybersecurity expectations.