What does MDR 2017/745 require?
Cybersecurity in medical devices is no longer just a technical concern, it’s a critical requirement in ensuring patient safety. The European Medical Device Regulation (MDR) 2017/745 outlines clear expectations for device manufacturers to secure data, prevent unauthorized access, and maintain system reliability throughout the product’s lifecycle.
This article introduces the core principles of Confidentiality, Integrity, and Availability (CIA) and examines how MDCG 2019-16 guidelines emphasize the direct link between cybersecurity breaches and potential harm to patients. Protecting digital interfaces and communication channels is vital for clinical reliability.
We also explore the importance of adopting a continuous risk management process, including post-market monitoring and updates to keep pace with evolving threats. A special focus is given to the global harmonization efforts led by IMDRF, which provide a structured framework for secure-by-design development. A must-read for QA/RA professionals, designers, and MedTech teams who are shaping innovative yet compliant and safe medical devices.
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