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Whirlwind of Change: How New Standards, MDR, and Brexit are Impacting Biocompatibility

June 2, 2021

Thor Rollins

Because of the COVID-19 crisis, new Medical Device Regulations (MDR) have been pushed back one year. Not only has the delay given a respite to companies not ready for increased regulations but also has put the new MDR requirements in the same time period with the impact of Brexit and new ISO 10993 requirements. This Tech Talk discusses the current status of biocompatibility submission with MDR and Brexit and explains what others are doing to get ready.

Topics include:
  • What additional requirements are in the MDR?
  • What is being required now per ISO 10993?
  • How is Brexit impacting submissions to the UK?
  • Where is the industry currently at and how many companies feel ready for their first submission?
  • What have we learned from the first submissions under MDR?
  • What are others doing now to save time and money?


Dries Cardoen

Dries Cardoen

Inhalation, Transdermal and Topical Drug Products Expert

Dries Cardoen received his Ph.D. from the Faculty of Biology at the University of Leuven (Belgium) in 2011. After his academic career as a post-doctoral researcher, he started at Nelson Labs Europe in 2013 as Study Director in the Extractables & Leachables Department. He is currently responsible for the group of study directors that is...