We present a strategy to evaluate whether a medical device contains any carcinogenic, mutagenic, or reproductive toxicants (CMRs) at amounts in excess of 0.1% for compliance with requirement 10.4 of the MDR. In cases where supplier information isn’t available, and extractables chemistry testing is being used to evaluate biocompatibility, this data may be used as evidence that the device materials are CMR free.
What you’ll learn:
- What specific chemicals are CMRs? Which list should be used?
- Feedback received from EU NB on proposed strategies to address CMRs
- Proposed flow and methodology to experimentally evaluate CMRs