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Benny Lyvén
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EU reference laboratories
The European Commission has designated 5 different labs in Europe to become EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs) according to Article 100 of Regulation (EU) 2017/746.
RISE has been designated in the scope "Respiratory viruses that cause life-threatening diseases".
Testing in the reference laboratory
The EURLs for high-risk in vitro diagnostic medical devices (IVDs) are designated according to Article 100 of Regulation (EU) 2017/746. This 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 EURLs: advisory ones and those related to conformity assessment, particularly of the highest risk, i.e., 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 EURLs will:
- verify the performance of class D devices and compliance with common specifications,
- perform batch testing of class D devices.
The designated laboratories are:
1. RISE Research Institutes of Sweden, Sweden
2. Consulting Químico Sanitario SLU, Spain
3. Instituto de Salud Carlos III, Spain
4. EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Germany
5. Consortium, Servicio Madrileño de Salud (SERMAS), consisting of 3 hospitals:
a. Hospital General Universitario Gregorio Marañón, Spain
b. Hospital Universitario la Paz, Spain
c. Hospital Universitario Ramón y Cajal, Spain
Method
For new products, a performance test will be carried out, for products already tested, there will be a batch test.
All communication from manufacturers is through Notified Body.
Delivery
The EU reference laboratories are working with Notified Bodies and delivering to them.
FAQ
FAQ
What scopes of the class D devices are covered by the EURLs?
- Hepatitis and retroviruses
- Herpesviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
Which scope are covered by which EURL?
Can be found in the Implementing act: https://eur-lex.europa.eu/eli/reg_impl/2023/2713/oj
Status of EU reference laboratories
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.
What will the cost be for using the EURLs?
The prices that the EURLs are going to use are according to Commission Implementing Regulation (EU) 2022/945
How do notified bodies work with EURLs?
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.
How do notified bodies work without EURLs?
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.
What if there is no EURL for an class D testing scope yet?
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)
