Clinical evaluation is now more important than ever under EU-MDR

Insights from a Let's Talk Risk! conversation with Florian Tolkmitt

Note: this article highlights key insights gained from a conversation with Florian Tolkmitt as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below.

Summary

Here are a few key points that emerged from our discussion:

1. There is a new scrutiny on clinical evaluations in the EU

2. Clinical investigations provide one type of data for clinical evaluation

3. Manufacturers are currently challenged to show they have sufficient data to comply with EU-MDR requirements

4. Establishing thresholds for risk management and clinical evaluation continues to be a challenge

5. Think of clinical evaluation as a process, not simply a document for compliance

Let us dive in.