Nuevos laboratorios de referencia de la UE para IVD de alto riesgo

On 17 December 2025 the Official Journal of the European Union published Commission Implementing Regulation (EU) 2025/2526, amending Implementing Regulation (EU) 2023/2713.

This Regulation both corrects the designation of an existing EU reference laboratory (EURL) and designates new EURLs for specific categories of in vitro diagnostic medical devices (IVDs).

Key Points

EU reference laboratories (EURLs) designated for:

• 2 are designated for detection or quantification of markers of parasite infection
• 3 are designated for detection of blood grouping markers

The designation of additional EURLs further strengthens the IVDR conformity assessment system, particularly for high-risk IVDs (e.g. Class D devices). EURLs contribute to greater consistency, scientific robustness, and confidence in performance evaluation, supporting harmonised implementation of IVDR requirements across the EU.

What Does This Mean for You?

Manufacturers of relevant IVDs should assess whether their devices fall within the scope of the newly designated EURLs, as this may impact conformity assessment requirements.

In particular, for applicable devices, manufacturers should anticipate additional involvement of EURLs in performance verification and assessment processes.