Background 

• History of the Medical Devices Directive (MDD) and overview of the MDR
• Definitions and scope
• Dates and timelines

Making Available and Putting into Service of Devices 

• Market placement and distance sales
• Technical requirements for products and technical documentation
• Manufacturer’s responsibilities
• Authorized Representative’s responsibilities
• Importer and distributor requirements
• Person responsible for regulatory compliance and CE marking

Identification and Traceability of Devices 

• UDI

Notified Bodies 

• Authority responsible for Notified Bodies
• Notified Body requirements

Classification and Conformity Assessment Routes (New Annexes)

• Classification and conformity assessment of medical devices
• Conformity assessment routes and procedures

Clinical Evaluation and Clinical Investigation 

• Expansion of clinical evaluation
• Clinical investigation supporting performance
• Requirements of clinical investigation

Post-Market Surveillance, Vigilance, and Market Surveillance 

• Post-Market Surveillance requirements
• Vigilance activities and reporting
• Trending and analysis of incidents or actions
• Field safety handling and analysis
• Market surveillance proactive approach

Cooperation between Member States, MDCG, and Expert Panel 

• New central body and its responsibilities
• Cooperation between different groups

Confidentiality, Data Protection, Funding, and Penalties 

• Confidentiality and data protection