Beyond the Mailbox: Your EU Rep's Critical MDR & IVDR Duties

This episode delves into the critical role of the European Authorised Representative (EC REP) for non-EU medical device and IVD manufacturers under the MDR and IVDR. We explore how the responsibilities have expanded beyond a simple administrative function to include significant legal liability and active compliance verification, making the choice of your EC REP a crucial strategic decision for successful market access. • What is a European Authorised Representative (EC REP)? • Why is appointing an EC REP mandatory for non-EU manufacturers? • How did the MDR and IVDR change the legal liability of the Authorised Representative? • What specific compliance documents must your EC REP verify before you can market your device? • Can your Authorised Representative be held responsible for your defective devices? • What is the relationship between an Authorised Representative and the Person Responsible for Regulatory Compliance (PRRC)? • How does the EC REP participate in post-market surveillance and incident reporting? • What should you look for when selecting an Authorised Representative for the EU market? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.