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ISO 10993-18 in the MDR: understanding the restrictions and risk assessment for compounds which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties (section 10.4)

Published Date: April 23, 2020

Presenter: Annelies Vertommen PhD (Scientific Improvement Manager – Nelson Labs Europe)

This presentation explains to what extent a chemical characterization study (ISO 10993-18) can assist in meeting the requirements of section 10.4 of the MDR. A workflow for both the labeling obligation as well as the risk assessment is proposed. This requires a clear understanding of the difference between a targeted and screening analytical approach and the corresponding level of quantification.

The presentation was recorded at our Open House Event in Leuven on 4 March.


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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