Implementing Regulation (EU) 2025/2526: Correction and Designation of EU Reference Laboratories for In Vitro Diagnostic Medical Devices

Content

The Commission Implementing Regulation (EU) 2025/2526, published on 17 December 2025, amends Regulation (EU) 2023/2713 to correct the designation of an existing consortium and appoint new EU reference laboratories for:

detecting and quantifying markers of parasitic infection;
detecting blood grouping markers.

Key Dates:

Entry into force: 3 days after publication.
New designations effective: May 1st, 2026 for tasks under Article 100 of Regulation (EU) 2017/746.

Impact: These changes aim to strengthen the reliability of conformity assessments and ensure the availability of reference laboratory services for Class D devices.

DOWNLOAD THE IMPLEMENTING GUIDANCE (EU) 2025/2526