28-29 October 2019 | Brussels (Belgium)

Following the success of the Conference in Prague in 2016, Berlin in 2017 and Brussels in 2018, at this forth Conference 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 conference of noteworthy quality.

Topics to be covered, among others will be:

  • Implementation of the New Regulations: State of the Play
  • View of a Notified Body on the MDR Implementation Steps
  • Designation of Notified Bodies: State of Play
  • The Road to 2020: Overview of Regulatory Developments
  • Major Regulatory Compliance Challenges for the Industry
  • Challenges for the non-European SMEs
  • Challenges for National Competent Authorities
  • New Legal Challenges to the Medical Device Industry
  • Challenges Arising from the New Concepts in the Regulations Relating to Scope, Classification and General Safety and Performance Requirements
  • Quality Systems
  • Post-Market Surveillance
  • Practical Aspects of Clinical Evaluation: Before and After CE Marking under the MDR
  • 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
  • Medical Device Software in the European Union
  • Conflict Between Economic Operators

These topics will be updated further upon completion of the agenda

Join the RMD2019 Conference and benefit from expanding your network.