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.
Your MDR Strategy: Start with a Gap Analysis
Published In: Medical Design Briefs
April 1, 2020
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...
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...
BS, RM (NRCM), CBA (ASQ)
Audrey Turley has 20 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), and...