EUROPEAN REFERENCE LABORATORY EURL-IVD SERMAS CONSORTIUM

European Reference Laboratory for Class D in vitro diagnostic medical devices (EURL-IVD) in the categories: (I) Detection and quantification of bacterial infection markers (Treponema pallidum) and (II) detection and quantification of herpesvirus infection markers (Citomegalovirus and Epstein-Barr Virus).

On December 5, 2023, the European Commission published (Regulation (EU) 2023/2713) the designation of 5 laboratories in Europe as European Reference Laboratories (EURL) for high-risk in vitro diagnostic medical devices (IVDs) (Class D). These EURLs have been selected based on the criteria established in the Implementing Regulation (EU) 2022/944.

The consortium formed by the Medical Microbiology Departments of three hospitals belonging to the Madrid Health Service (SERMAS) has been one of the designated entities, these being Hospital Universitario La Paz, Hospital Universitario Ramón y Cajal and Hospital General Universitario Gregorio Marañón.

The EURLs will carry out tasks of conformity assessment of in vitro diagnostic medical devices as set out in Article 100 of Regulation (EU) 2017/746. In summary, the EURLs will be responsible for:
- Verifying the performance of Class D devices and compliance with common specifications.
- Conducting batch testing of Class D device products that already have the CE mark.
- Providing scientific advice to European institutions regarding these devices.
- Offering recommendations on reference materials and measurement procedures.
Specifically, the Consortium of Hospitals of the Madrid Health Service (EURL-IVD-SERMAS) will be responsible for verifying the performance of medical devices for the detection and quantification of bacterial infection markers (Treponema pallidum) and the detection and quantification of herpesvirus infection markers (Citomegalovirus and Epstein-Barr Virus).

The Microbiology Laboratories of the EURL-IVD SERMAS Consortium, as part of the EURL-IVD, contribute to the Network of European Reference Laboratories with decades of experience in the use and evaluation of medical diagnostic devices. This is evidenced by the thousands of samples processed daily among the three hospitals and the high quality of diagnostic results. The Medical Microbiology Services of the three Hospitals are equipped with state-of-the-art equipment and highly trained personnel. These Services also have demonstrated experience in serological techniques and molecular biology.

The microbiology laboratories that form the EURL-IVD SERMAS Consortium will act in a coordinated manner. These laboratories ensure the use of the same methodology and procedures to obtain comparable results.

The EURL-IVD will provide service to notified bodies for the evaluation of batches and performance verification of Class D devices according to common specifications or equivalent solutions.

The prices that the EURLs are going to use are according to Commission Implementing Regulation (EU) 2022/945 .

Rules for Setting the Fees for EU Reference Laboratories (EURL)

1.Fee Coverage Fees levied by EU Reference Laboratories may cover the following categories of costs:

1.Staff costs: Includes staff hours, travel, accommodation, and subsistence costs.

2.Equipment costs: Applicable when the equipment is not provided by the manufacturer of the device to be tested.

3.Consumables, test specimens, and reference materials.

4.Shipping costs: For sample transportation.

5.Translation costs.

6.General laboratory operation costs.

2.Outsourced Testing When a task is outsourced to another laboratory under a contract, the fees may include the costs paid to that laboratory for completing the requested task.

3.Fee Calculation Principles

1.Fees must be non-discriminatory, fair, reasonable, and proportionate to the services provided.

2.Fees shall be calculated based on incurred costs.

3.If calculating the incurred costs for a particular category (staff, equipment, consumables, shipping, translation) is unreasonably burdensome, the EURL may estimate the costs based on average costs for that category.

4.The fee for general operation costs shall be determined as a percentage of the combined costs of the other categories and may not exceed 7% of those costs.

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.This applies only to devices whose intended use is related to class D

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 including international standards:

Reference materials for Scope 2 (herpesviruses):
- Target pathogen: Human Cytomegalovirus (CMV)
Marker: CMV Antibodies

Reference Material: WHO 1^st International Standard for CMV IgG

Reference and provider: 136616/17 (PEI)
- Target pathogen: Human Cytomegalovirus (CMV)
Marker: CMV DNA

Reference Material: WHO 1^st International Standard for CMV for nucleic acid amplification techniques

Reference and provider: 09/162 (NIBSC)
- Target pathogen: Epstein-Barr Virus (EBV)
Marker: EBV Antibodies

Reference Material: N/A

Reference and provider: N/A
- Target pathogen: Epstein-Barr Virus (EBV)
Marker: EBV DNA

Reference Material: WHO 1^st International Standard for EBV for nucleic acid amplification techniques

Reference and provider: 09/260 (NIBSC)

Reference materials for Scope 3 (bacterial agents):
- Target pathogen: Treponema pallidum (TP)
Marker: TP Antibodies

Reference Material: WHO 1^st International Standard for human syphilitic plasma IgG

Reference and provider: 05/122 (NIBSC) (currently not available). NIBSC is preparing new material (probably available in October 2026)
- Target pathogen: Treponema pallidum (TP)
Marker: TP Antibodies

Reference Material: WHO 1^st International Standard for human syphilitic plasma IgG and IgM

Reference and provider: 05/132 (NIBSC) (currently not available) NIBSC is preparing new material (probably available in October 2026)

In relation to reference measurement procedures of higher metrological order (II), some database 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:

Establishment and management of a network of national reference laboratories

Contact

Email: eurl-ivd.sermas@salud.madrid.org

Other designated institutions:
- RISE Research Institutes of Sweden – Sweden
- Consulting Químico Sanitario SLU – Spain
- Instituto de Salud Carlos III – Spain
- Paul-Ehrlich-Institut – Germany

Class D device groups covered by the EURL to date:
- Hepatitis and retroviruses
- Bacterial agents
- Herpesvirus
- Highly pathogenic respiratory viruses

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