The New World Of EU Regulation – MDR And IVDR: How To Prepare And Avoid The Hurdles

This podcast give a timely update on the progress of the EU Medical Device and IVD Regulations, and addresses what will change for medtech companies wishing access the EU market in the future. The texts of the new Regulations were published on May 5 and enter into force on May 25. Medtech Insight's EU regulatory affairs expert Amanda Maxwell takes a stakeholder's eye view of how to prepare for the Regulations, which will apply after transition periods.