Development and Regulation of In-house In Vitro Diagnostics (IVDs)

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. 

Agenda
Download the agenda