The new Cyber Resilience Act (Regulation EU 2024/2847), effective from December 2027, introduces strict cybersecurity requirements for all CE-marked electronic products. The Medical Device Regulation (MDR 2017/745) further emphasizes data protection and the resilience of connected systems. In this landscape, designing embedded systems requires a holistic approach that combines certified hardware components with advanced software strategies.
From Secure Elements and HSMs to technologies like ARM® TrustZone and Secure Enclave, the latest generation of microcontrollers integrates protection features to manage cryptographic keys, isolate secure domains, and prevent unauthorized access. On the software side, mechanisms such as Secure Boot, Secure Update, and TLS protocols are essential to ensure firmware and data authenticity, confidentiality, and integrity.
The article offers a detailed overview of today’s available technologies, presenting a comprehensive guide to solutions aligned with EU cybersecurity regulations and adaptable to various MedTech scenarios.
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Download the full PDF or explore the article Cybersecurity for medical devices: what MDR requires.