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Extractables and leachables testing of a combination device: testing in between regulations for pharmaceutical products and medical devices

Published Date: November 10, 2020

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.


Annelies Vertommen

Chemical Characterization of Medical Devices and Compendial Testing Expert

Annelies Vertommen started her career at Nelson Labs as a Study Director for extractables and leachables projects for the pharmaceutical industry. In recent years, her focus changed to chemical characterization studies for the medical device industry. She closely follows all changes in this field by actively participating in the ISO10993-18 committee and following the discussions in the ISO 10993-17 committee.

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