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Medical Devices

Use of Real World Evidence for Regulatory Making for Medical Devices and Diagnostics in EU: A Practical Guide

Tuesday, May 7, 2024
15:05 – 16:05 CEST
Location: C 01
Learning Level: Advanced
Description: We've developed an understanding document that will help MedTech and Notified Body in their usage of RWE for regulatory purposes. This guide will provide guidance on how to select the right data, which questions can be answered with RWE, and what sections need to be included in the reports.
The objective is also to clarify the right use of RWE for regulatory purposes, in the context of EU MDR. This clarification, this guide will help MedTech to provide the right level of quality in regulatory reports using RWE, and NB will save time in reviewing reports that comply with these guidelines.

Learning Objectives:

  • Assess Real World Data by answering the right questions
  • Use Real World Evidence properly
  • Identify where, when and how RWE can be used