Description: Applications to the MDR are very prescriptive and submitting the correct information, and being well-prepared can ensure that no applications are refused. This presentation will feedback on the experience of MDR conformity assessments and the lessons learned with a view to help manufacturers be better prepared for their MDR submissions. The session will combine views the two side of the process: Notified Body and manufacturer.
Learning Objectives:
Understand the main differences in the technical documentation review process by Notified Bodies under MDR, compared to MDD
Understand typical shortcomings in the first few MDR applications assessed by the Notified Body.
Identify areas of focus and key aspects of the Technical Documentation requiring attention to support successful certification
