EU Medical Device Regulation (MDR) – Updated CE Marking Process and ISO 13485:2016 Expectations

EU Medical Device Regulation (MDR) Updated CE Marking Process and ISO 13485:2016 Expectations is an event dedicated to the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

Topics

• EU Regulatory and Legislative Structure
• EU Directives -> 2 EU Regulations
• EU Definition of a Medical Device
• Why the change from Directives to Regulations?
• Key Agencies Involved
• Updated Role of the Notified Body
• Overview of CE Marking Process & Changes Resulting from the EU MDR
• Essential Requirements -> Safety & Performance Requirements
• Medical Device Classifications
• Conformity assessment
• Integration of Risk Assessment / Risk Management
• MDR Overview (by Article & Annex)
• Device Vigilance & Reporting System
• Medical Device Single Audit Program (MDSAP)
• ISO 13485:2016 Updates
• Tips on Working with Regulatory Authorities
• Global Impact of ISO 13485:2016 Certification and CE Marking

Who should Attend

• Executive Management
• Regulatory Affairs
• Quality Assurance
• Product Development
• Clinical research and medical operations
• Medical Device R&D
• Manufacturing / Distribution
• CROs
• Clinical trial supply