This page is for the public and healthcare professionals.
It describes what near patient testing (NPT) is and provides guidance on its use.
What are devices for near patient testing?
Devices for NPT are used to test outside of a lab, generally near to, or at the side of, a patient.
These devices are used by healthcare professionals in hospital or community settings.
They are not used for self-testing.
What are the requirements for near patient testing?
Devices for NPT must comply with national guidelines and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
For example, NPT device manufacturers must identify their devices and clarify the level of training, qualifications or experience needed by the user.
National guidelines for safe and effective NPT are available for users of NPT devices. This document clarifies the requirements for NPT devices and our role in regulating them.