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EU MDR Delay: What Does It Mean for Biocompatibility and Chemical Characterization?

Published In: MD+DI

The delay gives medical device engineers the chance for a gap analysis and an optimized testing plan, says an expert chemist and toxicologist.

The year 2020 was already going to be an “exciting” one for medical device companies, thanks to all the regulatory and standards changes with the new EU Medical Device Regulation (MDR) as well as ISO 10993-1, ISO 10993-18, and even ISO 18562, pointed out Matthew Jorgensen, PhD, DABT, senior chemist and toxicologist for Nelson Laboratories. He spoke in the webinar, “A Year of MDR Remediation: Strategies and Lessons Learned.” And then SARS-CoV2 “turned everything upside down, causing the MDR deadline to be delayed and causing everyone to rapidly shift their priorities during this time,” he said.

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Matthew R Jorgensen, Ph.D.

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. To characterize materials, Dr. Jorgensen has extensively used a wide variety of techniques including GC/MS, LC/MS, FTIR, UV/VIS, SEM, NMR, and several types of advanced spectroscopic techniques. His Ph.D. in Physical Chemistry from the University of Utah was based on the fabrication and analysis of titanium dioxide and silicon dioxide photonic crystals templated from the three-dimensional structure found in the exoskeleton of exotic weevils. During his time at the University of Utah, he received the Henry Eyring Research Fellowship, the DOW Chemical First Year Scholarship, and additional grants to travel and present his research at national and international conferences. His research has resulted in over 30 peer-reviewed publications.