4th EAAR Annual Congress

Congress on New Medical Device Regulations

28-29 October 2019

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.