The rise of near-patient and self-test devices
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.
What you'll find in our white paper
- Defining the regulatory landscape for NPT and ST devices
We describe how the In Vitro Diagnostic Medical Device Regulation (IVDR) shapes the regulatory landscape.
- The classification of NPT and ST devices
We outline the IVDR's categories of devices.
- Who uses NPT and ST devices?
We explore how the IVDR requires manufacturers to consider the technical knowledge, experience, education and training of the intended users.
- SGS as an IVDR Notified Body
As a designated IVDR Notified Body, we outline our capabilities and how we are ready to help.