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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 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...