MEDICAL EQUIPMENT & DEVICES  SGS


Navigating cybersecurity challenges in MedTech


How has the rising threat of cyberattacks has driven the implementation of stricter regulations?


By Luisa Rusconi, Senior Security Evaluator, SGS D


igital technologies play a crucial role in  


 growing risk of cyberattacks. With the rising frequency and sophistication of cyberattacks, regulations are increasingly mandating stricter security measures. Meeting these security requirements in the realm of medical technologies (MedTech) presents challenges,  complex array of standards and regulations that must be followed.


WHAT IS MEDTECH? MedTech refers to the application of technology  monitoring, treatment and patient care. It encompasses a wide range of products, including pacemakers, insulin pumps, magnetic resonance imaging (MRI) machines, patient monitors and  analysis software), and is reshaping the way we 


CYBERSECURITY THREATS  risks, as the threat of cyberattacks continues to rise. In 2023, the Identity Theft Resource Center reported 2,365 cyberattacks across all connected


 marks a 72 per cent increase in data breaches compared to 2021, which was itself a record. As the frequency of cyberattacks escalates,  equipment is either disrupted or manipulated, 


REGULATIONS Countering this threat led to stricter MedTech     These require:    manufactured per the latest standards, taking  cycle and risk management, including information  


minimum requirements concerning hardware, IT network characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.   consider the Guidance on Cybersecurity for


 harmonised standards.  a decision to delay the deadlines for standard   cybersecurity process standard that outlines life    harmonisation postponement is only a delay and   MedTech businesses.           (2023) recommends it as a framework for secure       software and hardware components should  Resilience Act (CRA), which came into force in  months.





cyberattacks on products with digital elements. It will impact the healthcare sector through a     security risk management, life cycle security and security by design principles. 


for safety and security will help manufacturers  compliance, reduce liability and differentiate their 


26 July/August 2025 Irish Manufacturing www.irish-manufacturing.com


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