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

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.

Learning Objectives:

• Upon completion of this course, attendees will have enhanced knowledge of the ever-changing landscape of Medical Device Regulation in the EU
• The content of this course is designed to simplify the understanding of requirements and to provide attendees with the latest insight on how changes are being viewed and implemented by companies marketing products in the EU

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

• Executive Management
• Quality Assurance
• Regulatory Affairs
• Clinical Research and Medical Operations
• Product Development
• Manufacturing / Distribution
• Medical Device R&D
• Clinical Trial Supply
• CRO's