2019 - EU Medical Device Regulation (MDR) – Updated CE Marking Process and ISO 13485:2016 Expectations

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