It is our pleasure to invite you to join us for The Virtual 5th EAAR Annual Conference on New Medical Device Regulations (RMD2021).
Following the success of the Conference in Prague in 2016, Berlin in 2017 and Brussels in 2018 and 2019, you will have the opportunity to gain a better understanding of the implementation of the new European regulations on medical devices at this Fifth Conference.
The application date of the Medical Device Regulation is only a few months away. Additional regulations (implementing acts) and new guidance are issued frequently adding to the complexity. It is important to keep up-to-date with the fast evolving compliance scene.
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.
We look forward to welcoming you online to RMD2021 – The Virtual 5th EAAR Annual Conference on New Medical Device Regulations.
Topics to be covered, among others will be:
- Implementation of the New Regulations
- Four Months To Go: Will Medtech Be Ready On Time For The MDR?
Legal Challenges Related to the Implementation of the MDR
- Challenges for National Competent Authorities
- The Challenge of the Implementation for the Notified Bodies
- Major Regulatory Compliance Challenges for the European Industry
- Major Regulatory Compliance Challenges for the Non-European Industry
- Scope, Borderlines and Classification
- Setting up Risk Benefit Analysis
- General Safety and Performance Requirements
- Clinical Evaluation Reports
- Best Methods for Using ISO 14155: 2020 to Comply with MDR Clinical Study Requirements
- Challenging Requirements of the MDR/IVDR: Focus on Quality Management Systems
- Post-Market Surveillance – A New Concept OR a Great Misunderstanding / The Importance of Post Market Surveillance
Eudamed and UDI, a Curse in Disguise
Vigilance – Are There New Reporting Requirements? How is the New Market Surveillance Being Applied?
- The Roles of the Authorised Representative and the Person Responsible for Regulatory Compliance in the New Regulations
- Special IVD Issues
- Medical Device Software in the European Union
- Patient Centric Medical Devices: “Custom-Made” Versus “Personalised” or “Patient Adapted” Devices
New UK Regulatory System for Medical Devices Following Brexit
Join the RMD2021 and benefit from expanding your network.