On 13 June 2025, NEMECYS co-organised a dedicated Stakeholder Workshop in Paris, together with four sibling projects — CYMEDSEC, ENTRUST, MEDSECURANCE, and CYLCOMED — all focused on cybersecurity for healthcare. The workshop titled “Innovative Solutions for Cyber Risk in Medical Devices: A Hands-On Workshop” aimed to present project activities, exchange experiences, and address regulatory challenges related to cybersecurity in Connected Medical Devices (CMDs).
The session featured Magdalena Mycek, Senior Specialist from the Department of e-Health, Ministry of Health of Poland, who provided valuable insights from a policymaker’s perspective, particularly regarding the implementation of cybersecurity measures in digital health and CMDs.
The NEMECYS team presented the project’s overall approach, tools, and case studies, with a particular focus on the Cyber Compass tool, which helps stakeholders navigate regulatory standards, guidelines, and best practices.
Following the discussions, Ms. Mycek invited NEMECYS to contribute to a task force operating under the MDCG 2019-16 guidelines. This task force focuses on addressing cybersecurity and regulatory challenges, including recommendations relevant to both MDCG 2019-16 and the broader Medical Device Regulation (MDR).
This invitation represents a significant opportunity for NEMECYS to ensure that its results directly contribute to shaping European regulatory developments in the field of CMD cybersecurity.