Connected devices are everywhere—monitoring patients in hospitals, managing energy in smart grids, powering autonomous vehicles, and keeping homes secure. Each device tells a story of innovation. But in the European Union, the next chapter of that story will be defined by the Cyber Resilience Act (CRA).
By 2027, CRA requirements will apply to virtually every connected product sold into the EU. From MedTech to manufacturing, automotive to smart infrastructure, compliance is becoming the new passport for market access.
The CRA introduces 22 Annex I obligations that cover the entire device lifecycle—from secure design and provisioning to patch management and vulnerability response to long-term update support.
For IoT and MedTech manufacturers alike, this means:
Cybersecurity as a condition of entry. Devices must prove security at launch to access the EU market.
Ongoing accountability. Regulators can request compliance records at any stage.
Severe consequences. Non-compliance risks market removal and fines up to €15 million or 2.5% of global revenue.
CRA makes cybersecurity and compliance part of every device’s trust story—not just a final box to check.
Unlike standalone medical devices, IoT ecosystems are sprawling. Devices often integrate with cloud services, mobile apps, and third-party software, creating a supply chain of risks that span industries and borders.
To achieve CRA readiness, IoT manufacturers must demonstrate:
Trusted identity from the start. Devices provisioned with secure credentials at manufacture.
Lifecycle resilience. Secure over-the-air updates, patching, and SBOM validation.
Audit-ready proof. Compliance records that reflect the entire device lifecycle.
In short: IoT compliance isn’t just about one device—it’s about securing entire ecosystems.
Meeting CRA requirements is rarely a solo effort. IoT manufacturers face a web of interdependent challenges, from embedding security at the point of manufacture to proving compliance years into a product’s lifecycle. That’s where partnership becomes essential.
¶ºÒõ¹Ý provides the foundation. With solutions like Device Trust Manager, TrustCore SDK, and the ¶ºÒõ¹Ý ONE platform, manufacturers can embed trusted identities, validate updates, generate SBOMs, and maintain compliance records from day one. These capabilities ensure that every device begins its journey with security built in.
and bring the field expertise. With decades of experience in automotive, MedTech, manufacturing, and smart infrastructure, both Concept Reply and Digital Reply know how to translate compliance requirements into real-world deployments. Their teams help manufacturers integrate ¶ºÒõ¹Ý’s security infrastructure into complex IoT ecosystems, validate systems in the field, and ensure devices remain compliant long after launch.
Together, ¶ºÒõ¹Ý, Concept Reply, and Digital Reply offer more than point solutions—they create a pathway for manufacturers to implement CRA compliance without slowing innovation, ensuring connected devices across industries are not only market-ready but future-proof.
The CRA is more than a regulation—it’s a turning point for IoT. By embedding compliance into design and deployment, manufacturers can build devices that not only meet requirements but also inspire long-term trust from customers, regulators, and partners.
Dive deeper into strategies for IoT readiness with ¶ºÒõ¹Ý, Concept Reply, and Digital Reply in our joint webinar, .