• Introduction to MDR
• Implementation timelines
• Regulatory expectations against various chapters
• Contents and Fundamentals of the Medical Device Regulation (MDR)
• Classification/Reclassification of Products
• Non-Medical Products within the Scope of the Medical Device Regulation (MDR)
• Common Technical Specifications
• New Basic Requirements
• Content Requirements for Technical Documentation
• Post Market Surveillance
• Scrutiny Procedure
• Validity of Conformity Assessment and Certification, Transition Periods
• Requirements for Different Actors, e. g.:
• Manufacturers
• Importers
• EU Representatives
• Distributors and Service Partners
• Role of Contact Person for Regulatory Compliance
• Eudamed Database
• UDI (Unique Device Identification)