The in vitro diagnostics (IVD) industry’s slow progress to meeting the May 2022 deadline for the new In Vitro Diagnostics Regulation (IVDR) may have a profound impact on market access to products and, ultimately, patient outcomes. 

The IVDR, alongside the Medical Device Regulation (MDR), provides a harmonised regulatory framework to ensure the safety and performance of devices. Major impacts of the IVDR include greater transparency, extended scope, increased oversight, heightened traceability, stricter requirements, as well as analytical performance and scientific validity.  These additional requirements have caused significant increases in workloads across the medical device value chain. 

In this whitepaper, we lay the groundwork for a successful transition by discussing:

• The current IVD landscape and immediate impact of the COVID-19 pandemic on the medical device industry
• Challenges across the IVD lifecycle from development through clinical investigations and regulatory approval
• Steps for implementing a successful transition strategy, including quality management system gap assessments and implementing technical file remediation