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: 3 February 2021 — See all updates

Documents

In vitro diagnostic point-of-care test devices

PDF, 221 KB, 22 pages

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Management and use of IVD point of care test devices

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Details

This Medicines and Healthcare Products Regulatory Agency (MHRA) guidance is 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 3 February 2021 + show all updates

1. 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.

2. 22 July 2005

   First published.