# In vitro diagnostic point-of-care test devices

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a6fd447d-df69-4811-bb37-fbc2f4020cc0
Type: Guidance
Published: July 21, 2005
Updated: February 3, 2021

> This guidance document issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) outlines the essential standards for managing Point of Care Testing (POCT) services within primary and secondary care. While the document is not an inspection report for a specific company and thus lacks specific inspection dates, it provides a comprehensive regulatory framework for healthcare providers, including hospitals, GP practices, and community clinics. The guidance is intended for managerial, scientific, technical, and clinical staff to ensure diagnostic accuracy and patient safety. The main issues addressed include the potential for inconsistent testing quality and the need for rigorous technical oversight in decentralized settings. To ensure compliance, the MHRA requires healthcare organizations to implement structured management systems and involve specialized laboratory staff in the oversight of POCT. Required actions include establishing clear clinical governance, ensuring all testing personnel are adequately trained, and maintaining equipment according to standardized protocols. By following these principles, providers can mitigate risks such as incorrect diagnoses or improper device handling, ensuring that testing performed at the patient's side is as reliable as traditional laboratory analysis.

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## Content

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

## Attachments

- [In vitro diagnostic point-of-care test devices](https://assets.publishing.service.gov.uk/media/601a8c988fa8f53fbdc27dcc/Management_and_use_of_IVD_point_of_care_test_devices.pdf)
- [Management and use of IVD point of care test devices ](/government/publications/in-vitro-diagnostic-point-of-care-test-devices/management-and-use-of-ivd-point-of-care-test-devices)