Diagnostics and Personalized Medicine Conference

The regulatory framework for in vitro diagnostics (IVD) in Europe is changing following the introduction of the new In Vitro Diagnostic Regulation (IVDR), which entered into force with its publication on 26th May 2017. Following a 5-year transition period the IVDR will come into application on 26th May 2022, replacing the existing IVD Directive (98/79/EC; IVDD). The introduction of this new regulation has major impacts for precision medicine with the introduction, for the first time, of specific regulations for companion diagnostics in Europe. (CDx) devices will be regulated by designated notified bodies with clear requirements on vital aspects of device performance and oversight to ensure that the quality, safety, and performance of these devices is appropriate for their intended purpose. IVDR also, for the first time, regulates in-house tests offered by Single Healthcare Institutions (SHI) which will also have implications for the provision of testing for precision medicines. In this session we will:

• Describe the changes being introduced by IVDR
• Explain the implications of these changes and their impact on precision medicine
• Discuss and debate the opportunities and challenges posed by IVDR on the provision of current and future precision medicine