Medical technology is one of the most heavily regulated industries, and for good reason, as the safety, quality, and efficiency of medical devices directly impact patient care. With the introduction of the European Union’s Medical Device Regulation (MDR), the requirements for manufacturers, suppliers, and medical facilities have increased significantly. These new regulations aim to ensure greater transparency and higher safety standards, but at the same time pose major challenges for companies and hospitals.
But what does the MDR mean for the medical technology industry? In this article, we explain the most important innovations, challenges, and opportunities of this regulation and provide a comprehensive insight into its effects.