Drägerwerk AG & Co. KGaA, Moislinger Allee 53-55, 23558, Lübeck, Germany
*Corresponding author. E-mail address: holger.wagner@draeger.com (H.Wagner)
Online Published on 20 January, 2026.
The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) introduced stringent requirements for clinical evidence, device reclassifications, and more robust post-market surveillance measures, creating significant challenges for the medical technology industry. The compliance of a portfolio exceeding 2,500 products within Dräger’s Hospital Consumables and Accessories (HCA) Business Unit was managed, with MDR certification achieved prior to the regulatory deadline of May 26, 2024.
The study examines a methodological shift in Regulatory Affairs (RA) from a post-development review function to a proactive consultancy role. By optimizing processes, driving cultural change, and embedding RA expertise early in the R&D V-Model alongside Product Management (PM), this methodology streamlined development timelines, reduced costs, and prioritized resources for critical markets. The result was enhanced operational efficiency and adaptability on a global scale.
MDR, Regulatory Affairs, Change Management, Medical Devices, Compliance, TRIZ, QSR, QMSR
