EU reference laboratories

- Hepatitis and retroviruses
- Herpesviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases

Can be found in the Implementing act: https://eur-lex.europa.eu/eli/reg_impl/2023/2713/oj

The designation act includes transitional arrangements to allow the EURLs to form a network and harmonize their working methods and for manufacturers and notified bodies to adapt their processes to include EURL testing.

The EURLs are expected to take up their tasks in the conformity assessment of devices on 1 October 2024.

At the moment all EURLs are creating a network to coordinate and harmonize their working methods. They are all both working as a whole network with all laboratories as well as scope specific networks. The general network and the sub-networks works on harmonization of methods, procedures, processes, etc. in particular on common laboratory test procedures for performance verification and batch testing of devices. The works also will also adopt common rules of procedure. RISE is coordinating this work.

The fees 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)

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.

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.

Fee Calculation Principles
1. Fees must be non-discriminatory, fair, reasonable, andproportionate 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 costsshall be determined as a percentage of the combined costs of the other categories and may not exceed 7% of those costs.

We are currently working together with the NBGC Med-IVD Class D on how the EURLs and NB will be working together.
The EURLs will have contact with the Notified bodies for testing of devices and not with the manufacturers.

For class D devices must be tested by the EU reference laboratory before they may be placed on the market, regardless of whether or not they are novel. There are two key types of testing – verification of performance and batch testing.

Regarding the conformity assessment of devices without a designated EURL, they may still be certified by notified bodies and placed on the EU market according to Regulation (EU) 2017/746.

The EURL-related elements of the conformity assessment do not apply to them until an EURL is designated. Please see MDCG 2021-4 for guidance on how the EURLs should be integrated into the conformity assessment process when designated.

For the remaining 4 categories, namely arboviruses, haemorrhagic fever and other biosafety level 4 viruses, parasites and blood grouping, there were either no laboratories that satisfied the criteria or their combined capacity was insufficient to cover the expected volume of requests. There has been a call for interest out for the remaining scopes, which is now processed by EC. Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices - European Commission (europa.eu)

According to IVD regulation 2017/746, 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.

Information on (i) suitable reference materials:

EURL Scope 5, respiratory virus

Pathogen: SARS-CoV-2
Marker: SARS-CoV-2 RNA
Reference material: 2nd WHO International Standard for SARS-CoV-2 RNA
Reference and provider: 22/252, NIBSC

Pathogen: SARS-CoV-2
Marker: SARS-CoV-2 Antigen
Reference material: 1st WHO International Standard for SARS-CoV-2 antigen
Reference and provider: 21/368, NIBSC

Pathogen: SARS-CoV-2
Marker: SARS-CoV-2 Antibody
Reference material: Second WHO International Standard for anti-SARS-CoV-2 immunoglobulin
Reference and provider: 21/340, NIBSC

Pathogen: SARS-CoV-2
Marker: SARS-CoV-2 Antibody
Reference material: 1st International Reference Panel for antibodies to SARS-CoV-2 variants of concern
Reference and provider: 22/270, NIBSC

Pathogen: SARS-CoV-2
Marker: SARS-CoV-2 Antibody
Reference material: 1st International Standard for antibodies to SARS-CoV-2 variants of concern
Reference and provider: 21/338, NIBSC

Pathogen: MERS-CoV
Marker: MERS-CoV Antibody
Reference material: 1st International Standard for anti-MERS-CoV immunoglobulin G (human)
Reference and provider: 19/178, NIBSC

Pathogen: MERS-CoV
Marker: MERS-CoV Antigen
Reference material: Not available
Reference and provider: Not available

Pathogen: MERS-CoV
Marker: MERS-CoV RNA
Reference material: Not available
Reference and provider: Not available

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:
• 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)

Please note that 100% of the cost for delivery/transport have to be paid by the manufacturer.

The kits should be sent to the following address:
RISE Research Institutes of Sweden AB
Att: EURL, Name
Brinellgatan 4, House 6 gate G
504 62 Borås
Sweden

EORI Nr. SE5564646874
VAT nr: SE556464687401

Companies that are not part of the European Union must create a Pro Forma invoice in order for the shipment to be cleared through customs to Sweden accompanied by a delivery note.

The Pro Forma invoice must contain the following information.
• The purpose of the export. (Use any of the following, “Sample for testing purposes according to IVD regulation” / “for in vitro use only” / “for testing purposes only” / “not for human use”)
• Contents/identity of the shipment. (Kit name, lot no.)
• Parcel type.
• Gross weight.
• Taric/HS code of the contents.
• The value of the contents followed by the text “No charge. Value for customs purposes only.”
• Country of Origin
• Delivery terms, Incoterms 2020 DDP Borås, Sweden.

The delivery note must contain (for both non-European companies and European companies):
• Product name and model.
• Number of items.
• Special information about the product. (The kits should be stored at the recommended storage temperature (e.g., 2-8°C).) This to avoid that the kits will be stored at too warm temperature in case there is any delay with the customs declaration. This special information must also be clearly and visibly written outside on the box.

Use express delivery or equal and make sure that the delivery will be made door-to-door to avoid unnecessary stops at airports or other storage terminals.

When the shipment is ready to be shipped, please contact us by e-mail and inform about the details including date, flight number or reference (track) number.