The 566-page Medical Device Regulation (MDR), which replaces the EU’s Medical Device Directive (93/42/EEC) and the Directive on Active Implantable Medical Devices (90/385/EEC), has caused much discussion, training, debate, and stress in the medical device industry since its publication in May 2017. To say nothing of the changes in device regulation, the aggressive three-year implementation goal of May 26, 2020 has the industry as a whole — manufacturers, laboratories, and regulators — strategizing diligently as we step into 2020. This article briefly examines the current state of the MDR, including deadline extensions announced in the second corrigenda, a strategy to address material information, and what should be included in a gap analysis.
Published Article
PUBLISHED ARTICLE
Your MDR Strategy: Start with a Gap Analysis
Published In: Medical Design Briefs
April 1, 2020
Thor Rollins
RM (NRCM)
Biocompatibility 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...
Audrey Turley
RM (NRCM), CBA (ASQ)
Director of Expert Advisory Services & Biocompatibility Expert
Audrey Turley has over 25 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert, having performed all the in vitro tests offered at Nelson Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods),...
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.
