The BioMed Alliance In Vitro Diagnostics (IVD) Task Force has written an article on the Critical Implications of the In Vitro Diagnostics Regulation (IVDR) for Innovation in Diagnostics, which is now online in HemaSphere here. The publication is very timely as it came just in time for the In Vitro Diagnostics Regulation (IVDR) Application date on 26 May 2022, which brings substantial differences in the approval and certification process of IVDs and additional requirements for diagnostic laboratories.
The article addresses different elements around the IVDR implementation and its consequences for innovation and the work of laboratories, including for the development and use of in-house devices. It builds on the conclusions from our recent survey addressing laboratory preparedness for the IVDR and provides recommendations on important challenges to be addressed and for the way forward.