To address the need for rapid diagnostics, near-patient testing (NPT) emerged as a critical solution, while in vitro diagnostic (IVD) tests became increasingly accessible to lay users during the 20th century, marking a significant shift in personal healthcare.
This decentralization of diagnostics supports patient empowerment, improves access to care and enables earlier interventions.
In our latest white paper, "IVDR Requirements for Near-Patient and Self-Test Devices", we explore the devices and how we can help.
We describe how the In Vitro Diagnostic Medical Device Regulation (IVDR) shapes the regulatory landscape.
We outline the IVDR's categories of devices.
We explore how the IVDR requires manufacturers to consider the technical knowledge, experience, education and training of the intended users.
As a designated IVDR Notified Body, we outline our capabilities and how we are ready to help.