We’ll be present at the 2nd Medical Devices Regulatory and Compliance Summit, where Annelies Vertommen will be presenting.
Proposing a testing strategy to meet both the labeling (CMR / ED) and safety evaluation requirements of CMR / ED substances as specified in the MDR, paragraph 10.4
During this presentation, Annelies will address:
- The difference in testing for labeling requirements for substances with risk of carcinogenicity, mutagenicity or reproductive effects (CMR) and/or substances with endocrine disrupting (ED) properties and testing for risk evaluation of the use of these substances (MDR, section 10.4)
- The difference in extraction methods used for both requirements: full dissolution/digestion of the device material versus the extraction conditions specified in ISO 10993-18
- The difference in analytical methods used for both requirements: a targeted versus a screening analytical approach
- Proposal of a 2-step workflow to meet both the labelling requirements of the MDR as well as safety evaluation requirements