Point-of-Care Testing (POCT) refers to diagnostic tests performed near the patient, designed to deliver rapid results without the need for a central laboratory. Although the term POCT is widely used, Regulation (EU) 2017/746 (IVDR) uses the term Near-Patient Testing (NPT) to describe this type of testing.
However, the key factor is not where the test is performed, but its intended purpose:
A POCT/NPT is regulated as an in vitro diagnostic medical device (IVD) only if it directly contributes to a clinical decision.
✔️ IVDR applies when:
- The test generates a result used for diagnosis.
- It replaces or complements a clinical laboratory analysis.
- The device (or its software) processes, interprets, or calculates clinical parameters.
Examples: rapid infectious disease tests, blood glucose meters, portable blood gas analysers.
✖️ IVDR does not apply when:
- The product only stores, displays, or transmits data.
- It is a support tool without a direct diagnostic function.
What the IVDR means for POCT
The IVDR significantly increases requirements to ensure that POCT devices perform reliably even outside controlled laboratory environments:
- Many POCT devices move from self-declaration to assessment by a Notified Body.
- Stronger need for clinical evidence based on real-world performance.
- Greater importance of usability (ISO 62366) due to the type of user and environment.
- Associated software is considered IVD software (IEC 62304 + cybersecurity).
- A stricter risk- and use-context-based approach.
National Framework in Spain: Real Decreto 192/2023
In Spain, the European IVDR framework is complemented by Real Decreto 192/2023, which adapts national legislation and sets out how in vitro diagnostic medical devices must be supervised, managed, and placed on the Spanish market. This royal decree defines specific obligations for manufacturers, distributors, and healthcare institutions, providing the local regulatory context that completes the practical application of the IVDR. mIVD Regulation in Spain: Royal Decree 942/2025 – SQS
Software in POCT/NPT
- If the software interprets, analyses, or contributes to a diagnostic conclusion, it falls under the IVDR.
- If it only displays or transmits data, it is not considered an IVD device.
Where it does apply, it must comply with IEC 62304, cybersecurity requirements, and full performance validation.
SQS: Your Partner in Compliance and Validation
At SQS, we support manufacturers and developers of POCT/NPT throughout the entire compliance process for the IVDR and Spain’s RD 192/2023. We provide software and hardware validation, usability evaluations, risk analysis, clinical performance verification, and technical documentation review—ensuring the device works reliably in real conditions and meets all regulatory requirements.
