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.