Entering the EU (European Union) under the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) can be complex and daunting for medical device companies. For companies outside the EU, understanding the roles and responsibilities of the Authorized Representative and Person Responsible for Regulatory Compliance is crucial for a successful market entry. https://www.freyrsolutions.com/blog/navigating-ear-requirements-for-market-entry-into-the-eu