The American Conference on the New European Regulations of Medical Devices
Date(s) – 13/06/2019 – 14/06/2019
0 h 00 min
RMD2019-USA will follow on from the success of its European predecessors, (Prague 2016, Berlin 2017, Brussels 2018). In conjunction with EAAR (European Association of Authorized Representatives), our excellent panel of experienced professionals in this field will once again ensure a conference of noteworthy quality.
Topics to be covered, among others will be:
• Implementation of the New Regulations
• The Road to 2020: Overview of Regulatory Developments
• Major Regulatory Compliance Challenges for the Industry
• Challenges for National Competent Authorities
• New Legal Challenges to the Medical Device Industry
• Scope, Borderlines and Classification
• General Safety and Performance Requirements
• Practical Aspects of Clinical Evaluation: What needs to be updated now and how to plan for Future Compliance under the MDR
• Impact of the MD/IVD-Regulations on Quality Management Systems
• View of a Notified Body on the MDR Implementation Steps
• Post-Market Surveillance
• Do you need to plan for PMCF and What are the Possibilities for Gathering PMCF Data?
• The Impact of Increased Transparency and Traceability Resulting from Eudamed and the Introduction of UDI Vigilance
• What can we Expect from the MDR Authorized Representative?
• Special IVD Issues
• Conflicts Between Economic Operators
These topics will be updated further upon completion of the agenda