How the EU IVDR opens doors beyond the EU

Under the IVDR, European CE Marking requires more time and resources from IVD manufacturers than ever before. However, as more countries adopt the EU's approach to medical device and IVD regulation, IVD companies will find themselves well positioned to access other markets beyond the EU once their IVDR CE Mark is in place. In this article, Dr. Oliver Eikenberg discusses the potential to leverage IVDR CE Marking to streamline global market access.