“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.
