The Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) introduced a new layer of oversight for high-risk IVDs (class D) by requiring performance verification and batch testing by designated EU reference laboratories (EURLs). This article outlines the transition from the former IVD Directive 98/78/EC (IVDD) — where notified bodies (NBs) conducted device verification using various alternative methods—to the EURL legal framework established under Article 100 of the IVDR. It summarizes the designation and technical areas (scopes) of these EURLs, the development of harmonized agreements and workflows between NBs and EURLs, and the phased implementation of performance verification (PV) and Batch testing (BT). Key operational steps, manufacturer obligations, and the establishment of batch testing criteria are described. This article concludes with an outlook on the expansion of the EURL network and its role in strengthening scientific rigor, regulatory consistency, and confidence in the safety and performance of class D IVDs across the EU.
ROSENDAHL Jennifer;
CARNELLI Marta;
VASS Panna;
AGRENIUS Karin;
LAAN Alex;
PATTEN Tom;
TKACHENKO Olga;
SAUER Aisha;
2026-05-07
Journal of Regulatory Affairs / RAPS
JRC146314
2376-6980 (online),
https://www.raps.org/resource/from-ivdd-to-ivdr-the-interplay-between-notified-bodies-and-eu-reference-laboratories.html,
https://publications.jrc.ec.europa.eu/repository/handle/JRC146314,
10.4108/eai.13-11-2024.2355687 (online),
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