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EURL-IVD
EU reference laboratories (EURLs)
On December the 5th 2023, the European Commission has designated 5 different labs in Europe according to Article 100 of Regulation (EU) 2017/746 as European Reference Laboratories for in vitro diagnosis tasks (EURL-IVDR). The designation was done by the following implementing act, Commission Implementing Regulation (EU) 2023/2713 designating EU reference laboratories in the field of in vitro diagnostic medical devices.
The main tasks of the EURL-IVDR are advisory and those related to conformity assessment, of the highest risk, class D devices. The EURLs were chosen on the criteria within and will work with the tasks listed in Commission Implementing Regulation (EU) 2022/944.
For conformity assessment of class D devices, the EURL-IVRD will:
- Verify the performance of class D devices and compliance with common specifications,
- Perform batch testing of class D devices.
Designated Laboratories
The designated laboratories are:
- RISE Research Institutes of Sweden, Sweden
- Consulting Químico Sanitario SLU, Spain
- Instituto de Salud Carlos III, Spain
- EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Germany
- Consortium, Servicio Madrileño de Salud (SERMAS), composed of 3 hospitals:
- Hospital General Universitario Gregorio Marañón, Spain
- Hospital Universitario la Paz, Spain
- Hospital Universitario Ramón y Cajal, Spain
Q&A
WHAT SCOPES OF THE CLASS D DEVICES ARE COVERED BY THE EURLs?
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The scopes covered by each EURL-IVDR are:
- DETECTION OR QUANTIFICATION OF MARKERS OF HEPATITIS OR RETROVIRUS: PEI and ISCIII
- DETECTION OR QUANTIFICATION OF MARKERS OF HERPES: SERMAS, CQS and ISCIII
- DETECTION OR QUANTIFICATION OF MARKERS OF INFECTION WITH BACTERIAL AGENTS: SERMAS, CQS and ISCIII
- DETECTION OR QUANTIFICATION OF MARKERS OF RESPIRATORY VIRUS: RISE and PEI
The Instituto de Salud Carlos III has been designated in the scopes “Hepatitis and retroviruses”, “Herpesviruses” and Bacterial agents” including:
- Hepatitis B, C, D and E; HIV and HTLV
- Herpesvirus: CMV and EBV
- Treponema pallidum
FEES
The fees that the EURL-IVDR are according to Commission Implementing Regulation (EU) 2022/945 with the following rules:
Fees must be non-discriminatory, fair, reasonable, and proportionate to the services provided and shall be calculated based on incurred costs. They may cover the following categories of costs:
- Staff costs: Includes staff hours, travel, accommodation, and subsistence costs.
- Equipment costs: Applicable when the equipment is not provided by the manufacturer of the device to be tested.
- Consumables, test specimens, and reference materials.
- Shipping costs: For sample transportation.
- Translation costs.
- General laboratory operation costs (7% maximum)
If calculating the incurred costs for a particular category (staff, equipment, consumables, shipping, translation) is unreasonably burdensome, the EURL-IVDR may estimate the costs based on average costs for that category.
RECOMMENDATIONS ON SUITABLE REFERENCE MATERIALS AND REFERENCE MEASUREMENT PROCEDURES OF HIGHER METROLOGICAL ORDER
According to regulation 746-Article 100-2h, EURLs have to provide recommendations on (i) suitable reference materials and (ii) reference measurement procedures of higher metrological order for their specific scopes.
The purpose of sharing this information is that class D IVD stakeholders have availability of references regarding standards and metrological traceability of IVD devices.
This information (i) is provided below in the next table including international standards:
In relation to reference measurement procedures of higher metrological order (ii), some databases can be consulted. The JCTLM Database lists higher-order reference materials, measurement methods and services to be used in calibration hierarchies for value assigning calibrators and trueness control materials for quantities measured by in vitro diagnostic medical devices. The listed reference materials, measurement methods and services when applied following the models described in ISO 17511:2020, ‘In vitro diagnostic medical devices —Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples’, can be used to establish metrological traceability.
Besides JCTLM, other publications in relation to metrological traceability have been also selected as possible source of recommended procedures of higher metrological order and general framework for this topic:
CLSI EP32 – Metrological Traceability and Its Implementation
ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement Results
Establishing metrological traceability in laboratory medicine
European Metrology Network (EMN) for Traceability in Laboratory Medicine (TraceLab Med)
Documentation
Contact
- Hepatitis y retrovirus
- Herpesvirus
- Agentes bacterianos
- Virus respiratorios que causan enfermedad potencialmente mortal