includes, above all, a sound and valid clinical evaluation.
This assessment forms the foundation of every medical device and is a key contributor to a successful conformity assessment. Get to know the possible clinical evaluation strategies and gain a deep understanding of the essential elements of testing in order to ensure long-term market success for your medical device.
The 3rd Medical Device Symposium is dedicated to the challenges and solutions surrounding clinical evaluation in a structured and comprehensive manner. In-depth presentations by selected experts and practical discussions with a wide range of stakeholders will provide participants with valuable insights into the latest developments, regulatory requirements and proven methods for successfully implementing the MDR.
Programme highlights:
- Regulatory requirements and test criteria for clinical evaluations
Dr. Tina Richter will open the symposium with a detailed analysis of the MDR and the review criteria for clinical evaluations. This introduction creates the basis for a deep understanding of regulatory expectations and gives participants the tools they need to meet the high requirements of the MDR.
- Clinical claims: Scientifically sound and regulatory compliant
Dr. Esra Gün and Dr. Micha Feld will shed light on how clinical claims can be scientifically substantiated and regulatory compliant. They show how the correct definition and evidence-based nature of claims not only overcomes regulatory hurdles, but also strengthens confidence in the products and increases their market opportunities.
- The central role of clinical studies: planning, implementation and evaluation
Dr. Andreas Pfaff will guide participants through the complex processes of clinical trial planning and implementation. He will explain how studies are designed to meet the strict requirements of the MDR and at the same time provide valid data to support the clinical benefit and safety of a product, scrutinising different study types.
- Equivalence approach under the MDR: possibilities and limitations
Dr. Florian Tolkmitt discusses the application of the equivalence approach under the MDR and highlights the specific requirements that manufacturers must meet in order to be able to use data from equivalent products. This presentation will also address the limitations of this method and provide insights into future regulatory developments.
- Effective communication with Notified Bodies: Strategies for success
Dr. Christian Schübel will focus on the different clinical evaluation strategies that can be discussed in dialogue with the notified body in order to master regulatory review processes, avoid potential pitfalls and make the conformity assessment process efficient.
- Long-term success under the MDR: the red queen hypothesis in practice
Dr. Martin von Rüden shows how even established products can be adapted to the new requirements of the MDR. The application of the Red Queen hypothesis illustrates why continuous adaptation and further development are essential in order to survive in a constantly changing market.
Date: 12 March 2025 | Location: NH Collection Berlin Mitte Friedrichstrasse, Berlin
The 3rd Medical Device Symposium 2025 offers a unique opportunity to gain a comprehensive understanding of the complex requirements of the MDR with regard to clinical evaluation and to learn practical strategies. Use this event to expand your knowledge, learn from subject matter experts and optimally prepare for the regulatory challenges.
The vibrant and dynamic city of Berlin, known for its history and innovation, opens its doors for an event that will not only enrich your professional knowledge, but also offer you the opportunity to network in one of Europe's most exciting metropolises. Be inspired by the atmosphere of a city known for its pioneering developments and open, forward-thinking attitude.
We look forward to welcoming you to Berlin!
Get further information here (in German)