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The due date for compliance to MDR is rapidly approaching. These new regulations in a €100 billion global market are bound to make an impact and create some challenges. The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are doing just that. These new laws are a big win for patients. But for medical device manufacturers, they’re creating more than a little confusion as to how to achieve labeling and product transparency.
As companies around the world scramble to meet these new regulations, here’s a summary of what’s changing and some of the implementation challenges that have already emerged.