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Whitepaper

WHITEPAPER

Understanding the EU Medical Device Regulation for Device Companies

The new European Union (EU) Medical Device Regulation (MDR) will impact medical device manufacturers’ product-development timelines. All companies intending to sell their devices in Europe must understand the new MDR and how it differs from the previous directives, especially in terms of new biocompatibility standard requirements. The regulation, which goes into effect in May 2020, mandates CE marking for some products that did not previously require it. The new regulation will require adherence to ISO 10993-1:2018, which has also been updated to have stricter guidelines in certain areas. This will make more testing necessary, that could take a significant amount of time to perform. Device companies need to account for this extra time and expense to avoid delays in EU product approvals.

 

Matthew Jorgensen

Matthew Jorgensen

PhD
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...

Audrey Turley

Audrey Turley

BS, RM (NRCM), CBA (ASQ)
Biocompatibility Expert

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...

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...

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