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Every device tells a story. In healthcare, those stories are deeply human—a continuous glucose monitor that empowers someone living with diabetes, a surgical robot guiding a delicate procedure, a wearable heart monitor alerting patients and providers in real time.

But behind every device’s story is another one: a compliance story. And with the European Union’s Cyber Resilience Act (CRA), that story is about to take center stage.

Compliance is no longer a checkbox

For years, regulatory compliance for connected devices was treated as the “final step”—the last box to tick before a product launch. Documentation was prepared, audits conducted, and certifications obtained, often long after design and development decisions were locked in.

The CRA flips that narrative. Compliance is no longer a static event; it’s a continuous responsibility. MedTech manufacturers must now prove not only that their devices are born secure but also that they remain secure and supported across their entire lifecycle.

That means:

• Secure design at the earliest stages.

• Documented processes for software updates and vulnerability remediation.

• Proof of identity, integrity, and attestation across the device lifecycle.

• Clear accountability long after launch.

This isn’t just about meeting regulations—it’s about embedding trust into every chapter of a device’s story.

What’s at stake for MedTech

The stakes couldn’t be higher. The CRA introduces tough enforcement powers, including fines of up to €15 million or 2.5% of global annual revenue. More critically, regulators can remove non-compliant devices from the EU market altogether.

But the bigger risk is trust. If a device is found to be insecure or unsupported, patients and providers lose confidence. And in healthcare, once trust is broken, it’s nearly impossible to restore.

Compliance, then, is not only about avoiding penalties. It’s about ensuring devices can tell the right story—one of safety, reliability, and innovation that patients, providers, and regulators all believe in.

The CRA as a new chapter in MedTech

The CRA reshapes how MedTech devices are designed, built, and supported:

• Compliance is continuous. Accountability spans from concept through decommission, not just launch.

• Updates are mandatory. Over-the-air patching and vulnerability response are no longer optional.

• Documentation must be dynamic. Proof of compliance is expected on demand.

• Innovation and compliance must coexist. Far from slowing progress, compliance becomes an accelerator for market access.

Our whitepaper—The EU Cyber Resilience Act: What Manufacturers Need to Know—breaks these requirements down in detail. But the headline is clear: Compliance is now a living narrative, not a static report.

How ������ helps write the compliance story

Meeting CRA expectations doesn’t have to slow innovation. ������ Device Trust solutions embed compliance into devices by design:

• ������ Device Trust Manager provides centralized visibility and enforcement, enabling proof of identity, update tracking, and audit-ready records.

• ������ TrustCore SDK delivers secure boot, cryptography, and provisioning so devices are born with trusted identity.

• enforces authorized code and secure updates in the field.

• ������ Software Trust Manager supports code signing, SBOM management, and update validation.

Together, these capabilities address 17 of the CRA’s 22 Annex I obligations, giving manufacturers a significant head start in proving compliance.

Compliance as a competitive advantage

Too often, compliance is seen as a burden. The CRA reframes it as an opportunity. Devices that can prove compliance from the start will reach markets faster, maintain access longer, and earn greater trust from regulators and patients alike.

Compliance built into design frees teams to innovate confidently. And for those who embrace compliance as part of their device’s story, it becomes a market differentiator—not just a requirement.

In short: Compliance isn’t the last page in the device lifecycle. It’s the opening line of every trust story.

Where to begin

Every MedTech manufacturer faces the same challenge: Moving beyond checkboxes to build compliance into every stage of the device lifecycle.

The good news? You don’t have to start from scratch. Our whitepaper, The EU Cyber Resilience Act: What Manufacturers Need to Know, maps the requirements and shows how ������ solutions address them.