In this article, we look at how the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 reshapes oversight for the highest‑risk IVDs. One of its most important elements is the creation of European Union Reference Laboratories (EURLs). These laboratories play a central role in ensuring the safety and performance of Class D devices. Article 100 defines their mission, and the Commission has since issued detailed implementing rules that explain how EURLs must be organised, resourced, and supervised.
For manufacturers, particularly those developing Class D assays, these requirements matter. EURLs can influence performance verification, batch testing, and overall timelines. Understanding when their involvement is triggered, and what they actually do, is essential for planning a realistic and compliant development pathway.
The Legal Backbone of EU Reference Laboratories IVDR
EU Reference Laboratories (EURLs) are a central element of the IVDR oversight framework. Article 100 IVDR establishes their mandate, defining their tasks and the criteria they must meet. These rules form the legal foundation for how the EU evaluates the highest‑risk IVDs.
Two implementing regulations complete this framework. Commission Implementing Regulation (EU) 2022/944 sets out the detailed requirements EURLs must fulfil—covering personnel competence, equipment and reference materials, quality management systems, organisational structure, confidentiality, impartiality, outsourcing controls, accreditation, and ongoing compliance verification. A second act, Commission Implementing Regulation (EU) 2023/2713, designates the first EURLs and confirms the date from which they apply: 1 October 2024.
What EU Reference Laboratories Check for Class D Devices
Under the IVDR, certain Class D devices require EURL involvement. For these devices, EURLs independently verify performance claims and conduct batch testing as part of the conformity assessment. This adds an additional scientific check (beyond the notified body review) to confirm analytical performance and support lot release where required.
For manufacturers, this means planning ahead. Performance panels, reference materials, sample availability, and timelines must align with EURL capacity and testing requirements.
Key Requirements Defined for EU Reference Laboratories
The 2022/944 implementing act translates Article 100(4) into concrete operational obligations. To be designated, EURLs must demonstrate:
- Competent and independent personnel
- Fit‑for‑purpose equipment, specimens, control and reference materials
- Compliance with relevant international standards and best laboratory practices
- Robust organisational and administrative structures
- Confidentiality and data‑protection safeguards
- Clear independence and conflict‑of‑interest controls
- Strict oversight of any outsourced activities
- Appropriate accreditation
- Continuous verification of compliance, including Commission audits and the possibility of suspension if requirements are not met
These criteria ensure that EURLs maintain scientific integrity and high analytical standards.
Timeline and Transition for EURL Involvement
With the publication of Implementing Regulation 2023/2713, designated EURLs become operational from 1 October 2024. From that date, any new conformity assessment application falling within an EURL’s scope is expected to route performance verification or batch testing through the designated laboratory.
Devices already under assessment or already certified before this date may follow specific transition arrangements. Manufacturers should consult their notified body to understand case‑by‑case implications.
Practical Steps for Manufacturers
To prepare for EURL involvement under the IVDR:
- Align performance evaluation plans early with potential EURL panel requirements (e.g., specimen types, reference materials, pathogen/biomarker variability).
- Check whether your device falls within an EURL designation scope and adjust submission timelines accordingly.
- Engage your notified body to understand dossier routing, documentation expectations, and language requirements.
- Monitor NB and authority communications, which often provide clear summaries as EURLs scale up their activities.
Early alignment helps manufacturers avoid delays and navigate this additional scientific review step efficiently.
