EU 2017/745 MDR Basic Structure and Responsibilities to the Business Training

The training covers the following clauses of the EU 2017/745 MDR.

• Chapter I Scope and Definition
• Chapter II Making Available on The Market and Putting into Service of Devices, Obligations of Economic Operators, Reprocessing, CE Marking, Free Movement
• Chapter III Identification and Traceability of Devices, Registration of Devices and of Economic Operators, Summary of Safety and Clinical Performance, European Database on Medical Devices
• Annex VI Information to Be Submitted Upon the Registration of Devices and Economic Operators (The UDI System)
• Annex IX Conformity Assessment Based on A Quality Management System and on Assessment of Technical Documentation
• Annex X Conformity Assessment Based on Type Examination
• Annex XI Conformity Assessment Based on Product Conformity Verification
• Chapter V Classification and Conformity Assessment