Extractables and Leachables testing of combination devices requires a specific study set-up which differentiates from a typical chemical characterization study according to ISO10993-18. In this presentation, we will explain how a chemical characterization study of a combination device should be performed, based on a case study of an insulin device.
Furthermore, we will clarify how to integrate in the study set-up the requirement for Carcinogenic, Mutagenic and Reprotoxic Compounds (CMRs) as specified in section 10.4 in Annex I of the MDR. This requirement is especially important for products falling under article 117.
Finally, drug-device compatibility should not be neglected or forgotten in an overall biocompatibility evaluation.