IVD industry developments and the need for new regulatory frameworks
In recent years, the In Vitro Diagnostic (IVD) Industry has rapidly evolved to support different applications such as the screening, diagnosis and monitoring of chronic and infectious diseases. A large panel of diagnostic technologies is currently available on the IVD market, ranging from simple lateral flow assays (LFA) intended for self-testing to complex solutions integrating active devices used by central laboratories. IVD products also include reagents, accessories intended for use with IVD devices as well as software.
As many devices in the IVD field are intended to be used by lay persons (self-testing), the user interaction with the device plays a central role in the safety of the patient.
Moreover, an increasing number of IVD tests are coupled with software applications for data analysis and patient interaction. As a consequence of the technology advancement, new biomarker discovery and changes in the setting of use of the devices, a new risk classification system has been introduced by the In Vitro Diagnostic Regulation (IVDR), taking into account individual and public health risks.
Medidee’s services supporting the IVD Industry
The team at Medidee are specialists in translating IVD regulatory requirements into pragmatic, IVD-specific activities along the full IVDR certification process.
