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

Date2019-02-19

Deadline2019-02-19

VenuePalo Alto, USA - United States USA - United States

KeywordsEu medical device regulation; Eu mdr; eu mdr update; Eu ce marking

Websitehttps://www.complianceonline.com/eu-medi...

Topics/Call fo Papers

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

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Last modified: 2019-01-20 03:02:00