EU Medical Device Cybersecurity: Navigating MDCG 2019-16 Under MDR & IVDR

Medical Device Global Market Access · Feb 6, 2026 · 3m

This episode delves into the critical requirements for medical device cybersecurity in the European Union. We explore the concept of "state of the art" as defined by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), focusing on the key guidance document, MDCG 2019-16 Rev. 1. Learn how this guidance impacts your design controls, risk management, post-market surveillance, and change management processes to avoid common and costly audit nonconformities. - What does "state of the art" mean for medical device cybersecurity in the EU? - Why is MDCG 2019-16 Rev. 1 a…