A roadmap to meet 2022 deadlines, while navigating pandemic disruptions
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:
A roadmap to meet 2022 deadlines, while navigating pandemic disruptions.