Dear Colleagues

It is our pleasure to invite you to participate in the upcoming The 4th EAAR Annual Congress on New Medical Device Regulations (RMD2019) which will take place 28-29 October 2019, in Brussels, Belgium.

Following the success of the Congress in Prague in 2016, Berlin in 2017 and Brussels in 2018, at this forth Congress you will have the opportunity to not only expand your network but also to be privy to presentations that incorporate a wide variety of topics ranging important updates for Medical Devices and General Safety and Performance Requirements.

In conjunction with EAAR (European Association of Authorized Representatives), our excellent panel of experienced professionals in this field will once again ensure a congress 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 RMD2019 Congress and benefit from expanding your network.

We look forward to welcoming you to RMD2019 in the exciting and historical city of Brussels.

Mika Reinikainen
   Bioevents
RMD2019 Congress Chair
             Congress Organizer