Workshop - Development and Regulation of in-house IVDs

The DZIF Product Development Unit (PDU) would like to invite you to the workshop
“Development and Regulation of in-house IVDs” on the 7th of November 2024.

Content of the workshop
In vitro diagnostics (IVDs) are tests used for detection, monitoring, prediction or prognosis of 
diseases and are essential in clinical practice as well as clinical studies. Based on biological 
samples (e.g., blood, urine, tissues), the status of a person’s health is assessed. Whether it's 
an infectious disease or another serious health threat, IVDs can be used to identify or 
monitor diseases, help in treatment decision or prevent disease spreading. This underlines 
their important role within the health care system. In the European Union, IVDs fall under 
the scope of Regulation (EU) 2017/746 (in vitro diagnostic medical devices regulation, IVDR). 
In-house IVDs are exempted from most of the provisions of Regulation (EU) 2017/746, 
provided the health institution adheres to the conditions laid out in Article 5(5) of the 
relevant Regulation.

To gain more insight in the definition and regulation of in-house IVDs, this webinar focuses
on:

• Definition of in-house IVDs and differentiation from other devices
• Regulatory framework and responsibilities in Germany 
• Case study from academia 
   

Registration
Participation only for members of the DZG and CARB-X network.
For registration, please send an e-mail to OSRA@pei.de including your DZG or CARB-X 
affiliation and, if applicable, your DZIF or CARB-X project number.
Knowledge of the previous workshops is not required.
Participation is free of charge