Dear Colleagues

It is our pleasure to invite you to participate in the upcoming 3rd European Symposium on New Medical Device Regulations – Impact on Industry - The Race to Achieve Compliance by Deadline – (RMD2018) which will take place 22-23 October 2018, in Brussels, Belgium.

Following the success of the Symposium in Prague in 2016 and in Berlin in 2017, this third Symposium will address the important updates for Medical Devices.

In conjunction with EAAR (European Association of Authorized Representatives), our excellent panel of experienced professionals in this field will once again ensure a symposium 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
    Software
    Conflicts Between Economic Operators

These topics will be updated further upon completion of the agenda            

Join the RMD2018 Symposium and benefit from expanding your network.

We look forward to welcoming you to RMD2018 in the exciting and historical city of Brussels.

Mika Reinikainen
   Bioevents
RMD2018 Symposium Chair
             Symposium Organizer