Learn how Notified Bodies assess technical documentation, what questions to expect, and how to avoid delays on the path to certification.

A strong product alone is not enough to achieve MDR or IVDR certification. Ultimately, the quality of your technical documentation, and how effectively you respond to questions from the Notified Body, determines whether your medical device successfully reaches the market.

During a technical documentation review, Notified Bodies often raise critical questions regarding safety, performance, clinical evidence, and regulatory compliance. Inadequately supported responses can lead to significant delays, additional investigations, or even failure to obtain certification. Without certification, a medical device cannot be placed on, or remain on, the European market.

In this MedTech Twente session, you’ll gain unique insights into the journey from technical file to certificate through three different perspectives: the consultant, the Notified Body, and the manufacturer.

What to expect?

• Holland Innovative
  Drawing on experience from dozens of MDR and IVDR certification projects, Holland Innovative will share practical insights into the certification process. What questions do Notified Bodies ask most frequently? Where do companies typically run into difficulties? And what strategies can help streamline review cycles and improve the chances of a successful outcome?
• KIWA
  As a Notified Body, KIWA will provide a behind-the-scenes look at the assessment process. What do reviewers focus on during a Technical Documentation Review? Which deficiencies are encountered most often? And how can manufacturers avoid unnecessary delays during certification?
• Logiqcare (ORTEC)
  Logiqcare will share firsthand experiences from a recently completed MDR certification project for Software as a Medical Device (SaMD). What challenges did they encounter along the way? What questions did they receive from the Notified Body? And what lessons can other organizations apply to their own certification journeys?

Valuable insights for companies at any stage
This session is equally relevant for organizations that are still in the development phase. By understanding the expectations of Notified Bodies early on, you can make better-informed decisions around product development, clinical strategy, and technical documentation, helping to prevent delays later in the process.

In addition, there is increasing overlap between the questions raised by European Notified Bodies and the expectations of the U.S. Food and Drug Administration (FDA). The insights shared during this session are therefore highly relevant for companies pursuing international market access.

Why Attend?

✔ Learn from real-world MDR and IVDR certification projects
✔ Discover the questions Notified Bodies actually ask
✔ Gain insight into the review process from the assessor’s perspective
✔ Avoid costly delays and unnecessary rework
✔ Increase your chances of successful market access in Europe and beyond
✔ Connect with professionals from Twente’s MedTech ecosystem

Partners and sponsors

This session is organized by MedTech Twente in collaboration with Holland Innovative and Novel-T, with the help of our partners.