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Published Article


The Bumpy Road to MDR

Published In: Medical Device and Diagnostics Industry (MD+DI)

“The [European Union’s] MDR aims to provide a higher level of protection for patients, but the transition has been anything but smooth. Manufacturers are struggling to keep up with the extra checks, and the EU notified bodies are overwhelmed,” writes Helin Räägel, PhD and Senior Biocompatibility Expert at Nelson Labs, in an article published in Medical Device and Diagnostic Industry (MD+DI).

This article discusses the need for accommodating a reasonable transition from MDD to MDR while trying to optimize ways to ensure patient safety.


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Helin Räägel

Helin Räägel

Senior Biocompatibility Expert

Dr. Räägel is a globally recognized expert in medical device biocompatibility. She has extensive expertise in writing biological evaluations and assessments for regulatory submissions. These documents focus on using a risk-based approach in defining the path to evaluating medical devices, with US FDA and EU regulatory bodies as the primary audience. She works closely with...