Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation.

Abstract

We envision this work to assist researchers and medical device developers (beside other stakeholders) to better understand biomaterial-based medical device development and its approval process proposed by the new MDR and IVDR in the European Union, as more complex biomaterials emerge, with the MDR reflecting the progress in biomaterial discoveries. Additionally, insufficient international harmonization in regulatory laws and poor-quality data reporting contribute to the problem. This review desc