Extractables and leachables (E&L) testing of combination devices requires a specific study setup that differentiates from a typical chemical characterization study according to ISO 10993-18. This presentation explains how a chemical characterization study of a combination device should be performed based on a case study of an insulin device. It also clarifies how to integrate the requirement for carcinogenic, mutagenic, and reprotoxic compounds (CMRs) as specified in section 10.4 in Annex I of the MDR.
Viewers will learn about the unique challenges and considerations involved in E&L testing for combination devices. The session covers the importance of integrating CMR requirements into the study setup, ensuring that the testing process is comprehensive and compliant with regulatory standards. Additionally, the presentation highlights the significance of drug-device compatibility in the overall biocompatibility evaluation.
By attending this webinar, professionals involved in quality assurance, regulatory compliance, and R&D will gain valuable insights into designing and executing effective E&L studies for combination devices. This knowledge will help them ensure that their products meet stringent safety and performance standards, ultimately enhancing patient safety and product efficacy.