Health for humans, animals & plants

BASG discussion: Clinical trials of medical devices and performance studies of in-vitro diagnostics 2025

Date


13:00 to 17:00


Location

Online via Zoom

At this BASG meeting, we will inform you about current and future developments in the field of clinical trials of medical devices and performance studies of in-vitro diagnostics.

 

Contents

  • Regulation (EU) 2017/745 for medical devices, specifically for clinical investigations
  • Regulation (EU) 2017/746 for in-vitro diagnostics, specifically for performance studies
  • Update on the EUDAMED module for clinical trials/performance studies
  • National specificities, best practices and case studies
  • Information from the European working groups (CIE)
  • Exchange of experience and discussion

 

Target group

  • Employees of regulatory affairs departments of manufacturers of medical devices or in-vitro diagnostics
  • Employees of contract research organisations (CRO) and self-employed persons
  • Employees of coordination centres for clinical trials (KKS)
  • Academic researchers

 

Language

German

 

Registration information

Please register by 09.09.2025 at the latest.

This event will be held as an online-only event .

 

Technical management

Dr Stefan Strasser
Clinical Trials Department, Institute for Surveillance
stefan.strasser@ages.at
Medical Market Surveillance Business Unit, AGES GmbH

 

More information

To the registration form

Date


13:00 to 17:00


Location

Online via Zoom

Last updated: 13.04.2023

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