European Reference Laboratory

• The European Commission published on December 5^th, 2023 (Regulation (EU) 2023/2713) the designation of 5 laboratories in Europe as European Reference Laboratories (EURLs) for high-risk (Class D) in vitro diagnostic medical devices (IVDs).

• These EURLs have been selected based on the criteria set out in Implementing Regulation (EU) 2022/944

They provide service to Notified Bodies for, on Class D devices according to Common Specifications or other equivalent solutions

• Batch evaluation
• Performance verification

Device groups covered to date

• Hepatitis and retroviruses
• Bacterial agents
• Herpes viruses
• Highly pathogenic respiratory viruses

The cost of services is made according to the rules and calculations applicable according to the Implementing Regulation (EU) 2022/945

Designated entity formed by the Microbiology Services belonging to the Madrid Health Service (SERMAS) of:

• Hospital Universitario Ramón y Cajal
• Hospital Universitario La Paz
• Hospital General Universitario Gregorio Marañón

Laboratories

• Bring
  • Decades of experience in the use and evaluation of medical diagnostic devices to the European Reference Laboratory Network.
  • Thousands of samples processed daily - with high quality of diagnostic results -.

• Equipped with
  • State-of-the-art equipment
  • Highly trained personnel

• They have proven expertise in
  • Serological techniques
  • Molecular biology

• They guarantee, in order to obtain comparable results, the use of the same:
  • Methodology
  • Procedures

• Act in a coordinated manner

Evaluation tasks* -compliance of in vitro diagnostic medical devices-

• Provide
  • Scientific advice to European institutions -in relation to these devices-.
  • Recommendations on
    • Reference materials
    • Measurement procedures

• Verify
  • Performance of class D devices for the detection and quantification of infection markers
    • Bacterial - Treponema pallidum –
    • Herpesvirus
  • Compliance with common specifications

• Perform batch testing of Class D device products that already have the CE marker

*As referred to in Article 100 of Regulation (EU) 2017/746

• RISE Research Institutes of Sweden, Sweden
• Consulting Químico Sanitario SLU, Spain
• Instituto de Salud Carlos III, Spain
• Paul-Ehrlich-Institut, Germany