Regulatory Changes and Sustainability Trends for Medical Devices

Sabine Springael, Global Healthcare Steward, Dupont

Abstract: Robust risk assessments, detailed raw material compositional understanding, enhanced quality & traceability management along the supply chain, information sharing on the device down the supply chain are all important aspects of a device registration approval process. Upcoming application of the new EU Medical Devices Regulation (EU) 2017/745 planned this year is one example of the ongoing regulatory changes faced by Medical Device producers. When sustainability, circular economy and Green New Deal concepts also become important objectives how can medical devices producers and suppliers partner to better address these challenges together? This presentation will review some of the current regulatory and sustainability trends from a medical device supplier angle and raise some possible paths forward for producers and suppliers to partner in addressing these changes.

Biography: Sabine joined Dow Corning in 1994 as a development chemist. After 7 years in R&D activities related to silicone chemistry she joined the European regulatory group. She managed the EU chemical management compliance activities of Dow Corning before taking the role of EU Product safety and regulatory compliance group leader. In 2017, Sabine was named Global Product Steward for the Silicone healthcare business when this business was integrated into Dupont. In this position she is responsible to manage the business risk of positioning Dupont’s silicone materials on the regulated healthcare market. Assessing suitability of DuPont’s products for final customers applications and associated risks, guiding internal stakeholders to develop sustainable products aligned with applications and evolving regulations, giving stewardship insight into the business sustainability journey are some of the activities associated to her current position.