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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)

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.