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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Meeting Requirement 10.4 of the MDR – How to Address CMRs?

Published Date: August 26, 2020

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
Thor Rollins

Thor Rollins

BS, RM (NRCM)
Toxicology and E&L Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...

Matthew Jorgensen

Matthew Jorgensen

PhD, DABT
Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes research in organic chemistry synthesizing and analyzing a naturally occurring anti-cancer drug, computational treatment of photothermal spectroscopy, and professionally in a commercial lab. Most of his materials...

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