Header Artwork
Header Artwork

Published Article


The MDR Delay’s Impact on Regulatory and Testing

Published In: Orthopedic Design & Technology (ODT)

“The MDR requires manufacturers to submit significantly more documentation covering the total product lifecycle than previously under the MDD. A critical change with MDR is the clinical evidence necessary to demonstrate the safety and efficacy of the device… Manufacturers must be aware of how their product is now regulated to fully understand the level of clinical information required for their device and whether clinical testing is required,” explains Jordan Elder, Director of Regulatory Affairs at Regulatory Compliance Associates, in an article published in Orthopedic Design & Technology.

This article discusses what considerations medical device manufacturers should consider when looking at the revised deadlines for devices they’d like to keep on the EU market.


Read the Article

Thor Rollins

Thor Rollins

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...


Jordan Elder

Director of Regulatory Affairs, Regulatory Compliance Associates

Jordan Elder has almost 15 years of experience navigating regulatory pathways and identifying optimal regulatory strategies for both pharmaceutical and medical device companies. At RCA, he is responsible for providing clients with general direction, tactical objectives, and functional plans for their regulatory needs.