With the new EU MDR coming into effect May 2020, Notified Bodies are already providing many Medical Device Manufacturers Nonconformances against their interpretations of the new law. Notified Bodies have had very difficult EU Commission Joint Assessments and numerous Corrective Actions of their own which are making them very conservative on almost all interpretations. The tenor and feel for Notified Body audits has already started to change drastically. How will you handle technical disagreement? When is it appropriate to engage the EU Competent Authorities? Which Competent Authorities should you involve? Discuss these and other practical situations for managing change that the new EU MDR Technical Document Assessment and Audits are bringing about.