ARTICLE SUMMARY:
The new MDR heralds the beginning of a more regulated era in the medical device industry and with that come concerns about the requirements and costs that it imposes. But MDR doesn’t have to strike fear in the hearts and minds of medtech executives. Here are proven tools that companies can employ in order to ensure a smoother and less costly transition to the new MDR system. By Gloria Crispino, PhD, StatisticaMedica.
The new EU Medical Device Regulation (MDR), which is set to become effective on May 26, 2020, has sparked an uproar of worry throughout the medtech industry regarding the increased time and costs that the new rules will impose. High on the list of concerns is that the new rules will result in companies no longer looking to get CE marking for innovative technologies and introduce them in Europe first, meaning European patients will lag behind those in other nations in getting access to these life-saving devices.
