Medical Devices: from Promising Research to Clinical Implementation

The right steps, the right expertise, and the role of MDR/IVDR on the path to patient impact

Innovations in oncology increasingly involve medical devices, software/AI solutions, and in vitro diagnostics. Even when still in an early research phase, these innovations may (eventually) fall under the European Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) as they move closer to clinical application.

Navigating this regulatory and implementation landscape early in the research process can make the difference between a strong publication and successful integration into clinical practice. Regulatory requirements, strategic decisions, and timely involvement of the right expertise all influence whether, and how efficiently, an innovation ultimately reaches patients.

For whom?

Are you a researcher (PhD candidate, postdoc, project leader etc.) conducting research on an innovation that may eventually qualify as medical devices under MDR/IVDR, for example a diagnostic tool, software/AI application, device concept, or decision-support application? And do you aim to translate your work into clinical impact? Or are you working in the field of medical device innovation (e.g. business development, legal, valorization, TTO)? Or are you just interested in this topic?

Join this afternoon session!

What to expect?

This afternoon session will focus on:

  • Gain clarity on when and how MDR/IVDR applies to your innovation and research.
  • Understand why MDR/IVDR affects your entire innovation pathway, not just CE marking.
  • Learn what this means in practice for your research and how early decisions can help prevent delays and smoothen this process.
  • Learn from real-world experiences of researchers.
  • Get insight in the key steps and expertise needed to move from research to implementation.
  • Learn more about how KWF can support you in accelerating patient impact.

The program combines regulatory knowledge, expert insights, practical cases, and panel discussion, followed by a network opportunity.

Practical information

Date: Tuesday 19 May 2026
Time: 13:00 - 17:30
Location: Wonders of Work, Hoog Catharijne, Utrecht

Register here

Places are limited and subject to availability

Preliminary program

  • 13:00 – 13:30 | Registration & Coffee
     
  • 13:30 – 13:40 | Opening – Why this session?
    Introduction by KWF
     
  • 13:40 – 14:10 | The Bigger Picture: The MedTech Route
    An overview of the medical device pathway, which is a bumpy ride from research and practice, and how this differs from pharmaceuticals, including common “valleys of death” beyond CE marking. The session highlights the gap that often exists between regulatory approval and real-world implementation.
     
  • 14:10 – 14:45 | MDR/IVDR in Practice: From Theory to Application
    A practical introduction to when MDR/IVDR applies and how it affects research design, data generation and strategic decisions. How research differs from product development and it will offer some practical guidance and take aways.  MDR/IVDR is not a checklist - it is a strategic design choice.
     
  • 14:45 – 15:00 | Break
     
  • 15:00 – 15:30 | Peer Learning: Lessons from Researchers
    Short presentations sharing real-world experiences of researchers, challenges and lessons learned under MDR/IVDR.
     
  • 15:30 – 16:00 | Route & Support: How to Approach This Strategically
    An overview of the pathway from research to clinical implementation, who to involve and when, and other related topics such as IP and collaboration models.
     
  • 16:00 – 16:30 | Panel Discussion: From Regulation to Reality
    An interactive discussion with researchers and professionals on navigating MDR/IVDR, timing strategic decisions, and accelerating clinical implementation.
     
  • 16:30 – 16:40 | Closing Remarks (KWF)
    Summary of key takeaways and overview of how KWF can support researchers in advancing their innovation.
     
  • 16:40 – 17:30 | Networking

We look forward to welcoming you at this session!