ISCIII: EU Parasite Diagnosis Center

by Grace Chen
written by Grace Chen

The European Commission has designated key laboratories to evaluate the accuracy of in vitro diagnostic medical devices, crucial for detecting parasitic infections and determining blood types. This move, formalized through Implementing Regulation (EU) 2025/2526, aims to bolster the reliability of these tests, particularly those classified as high-risk (Class D).

New EU Labs to Verify Diagnostic Accuracy

These reference laboratories will play a vital role in ensuring the conformity of high-risk diagnostic products across Europe.

  • the European commission has officially designated EU Reference Laboratories (EURLs) for specific in vitro diagnostic medical devices.
  • The Carlos III Health Institute in Spain and Consulting Químico Sanitario SLU have been approved as eurls.
  • germany’s Referenzlabor für In-vitro-diagnostika am Paul-Ehrlich-Institut and Sweden’s RISE Research Institutes of Sweden AB will also serve as EURLs.
  • The new regulations will be fully applicable from May 1, 2026, with performance verification starting then for products undergoing conformity assessment.

Specifically, the Spanish Agency for Medicines and Health Products (Aemps) submitted two prosperous applications. The Carlos III Health Institute and Consulting Químico Sanitario SLU, both based in Spain, will now function as EURLs. A German center, Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, has been selected for blood group marker detection, alongside RISE Research Institutes of Sweden AB.

Did you know? – In vitro diagnostics (IVDs) are tests performed on samples like blood or tissue, *outside* the body, to diagnose disease or monitor health.

The Commission reached these designations after a thorough evaluation of applications submitted by Member States before June 6, 2025. Implementing Regulation (EU) 2025/2526 amends Implementing Regulation (EU) 2023/2713, refining the existing framework for EURL designation.

These designated laboratories will be responsible for assessing the conformity of Class D in vitro diagnostic products within their specialized areas. This includes providing advisory services and conducting performance verification and batch analysis, as outlined in Regulation (EU) 2017/746 of the European Parliament and of the Council.

What dose this mean for patients? More reliable diagnostic tests, especially for serious infections and blood disorders, leading to more accurate diagnoses and better treatment decisions.

The new regulations will be implemented in phases. specific scientific and technical assistance tasks will be applicable starting May 1, 2026. Though, the requirement for performance verification, as detailed in article 100 section 2 a), will apply to products for which manufacturers or authorized representatives formally request conformity assessment from a notified body on or after May 1, 2026.

Pro tip – Class D IVDs pose the highest risk to patients and require the most stringent conformity assessment procedures.

The Aemps initially announced a second call for EURL applications for IVDR on March 4, 2025. Following validation and verif

Reader question – How will these new EURLs collaborate with diagnostic manufacturers to ensure a smooth transition to the new regulations?
Dr Grace Chen – Health Editor

Board-certified physician and medical writer. Translates research into practical health advice and public-health coverage.

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