Cybersecurity requirements for medical devices in the EU and US - A comparison and gap analysis of the MDCG 2019-16 and FDA premarket cybersecurity guidance.

Abstract

The increasing use of connected medical devices has led to substantial cybersecurity challenges, putting patient safety and the integrity of healthcare infrastructures at risk. This study examines regulatory guidance on medical device cybersecurity in the European Union (guidance document of Medical Device Coordination Group MDCG 2019-16 revision 1) and the United States (US Food and Drug Administration Guidance on Cybersecurity) and identifies their strengths and weaknesses. First, the study co