Technical position paper · Europe 2026
Ten principles for governed Point-of-Care Testing
A framework for reliable, traceable and clinically useful testing near the patient.
From device to diagnostic service
Speed is not enough.
Speed is a property of a device; reliability is a property of the system.
Point-of-Care Testing becomes a healthcare service only when clinical need, intended purpose, responsibility, competence, analytical quality, traceability and result management are designed as one process.
A rapid number is not sufficient: it must come from a competent, traceable process capable of triggering the appropriate clinical action.
Operational framework
The ten principles
- 01Clinical need comes before technology.
- 02Intended purpose and context of use must coincide.
- 03Governance must be defined before implementation.
- 04Only trained and demonstrably competent operators.
- 05Pre-analytics are part of the result.
- 06Internal quality control, external assessment and comparability govern reliability.
- 07Every result must be fully traceable.
- 08Connectivity is part of patient safety.
- 09The process continues after measurement.
- 10Audit and indicators make the system improvable.
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Verifiable foundations
Regulation, quality and context of use
Regulation (EU) 2017/746 places intended purpose, performance and manufacturer information within a common European framework. ISO 15189:2022 is also applicable to POCT and supersedes the withdrawn ISO 22870. Local law still determines who may deliver each service and under which organisational responsibility.
- Regulation (EU) 2017/746 — consolidated text
- ISO 15189:2022 — official ISO record
- WHO — quality management for non-laboratory settings
Personal technical position paper, independent of individual brands or products. It does not replace law, manufacturer instructions, organisational procedures or the judgement of responsible healthcare professionals.
Invite the author to contributePOCT governance framework
Key questions for healthcare organisations
What is POCT governance?
POCT governance is the system of clinical responsibility, trained operators, procedures, quality controls, traceability, connectivity and result-management pathways that makes near-patient testing reliable and clinically actionable.
What should a POCT governance framework include?
It should define clinical need, intended purpose, accountable roles, operator competence, pre-analytical controls, internal quality control, external quality assessment, critical-result escalation, data continuity, audit and measurable KPIs.
How does ISO 15189:2022 relate to POCT?
ISO 15189:2022 includes requirements applicable to point-of-care testing. It supports a quality system built around competence, documented processes, risk management, result reliability and continual improvement.