Guidance

In vitro diagnostic point-of-care test devices

Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 22 July 2005
• Last updated: 14 July 2026 — See all updates

Documents

Management and use of IVD point of care test devices

HTML

Details

Guidance for people involved in the management and use of POCT services in primary and secondary care, including:

• managerial staff
• scientific staff
• technical
• clinical and nursing staff

While many of the issues are relevant to the performance of POCT in a hospital environment, the principles also apply to their use in:

• outpatient clinics
• community care
• GP practices
• community providers
• primary care settings

Published 22 July 2005

Last updated 14 July 2026 — Show all updates

1. 14 July 2026

   Removed outdated references in several sections. Updated section on training and UKAS accreditation for POCT. Updated section on incident reporting to clarify the scope and reporting routes for medical device incidents in different parts of the UK.

2. 3 February 2021

   Published a new version of the guidance following the end of the transition period. The guidance has now also been published in HTML format.

3. 22 July 2005

   First published.