On December 6, 2023 local time in EuropeThe European Commission has published Regulation (EU) 2023 2713 to designate EU Reference Laboratories (EURLs) in the field of in vitro diagnostic medical devices.
It is worth noting that this issue is at the level of regulation, which means that it is highly effective and must be enforced.
According to the requirements of the IVDR regulations:Class D in vitro diagnostic device products must be validated for performance and batch testing by an EU reference laboratory.
When the regulations take effect and are enforced
The regulation will enter into force three days after its publication in the Official Journal of the European Union and will be applicable from 1 October 2024.
The regulation designates 4 categories of products for EU reference laboratories
EU Reference Laboratory for the Detection or Quantification of Extracorporeal Diagnostic Reagents for Markers of Hepatitis or Retroviral Infection;
EU Reference Laboratory for the Detection or Quantification of Extracorporeal Diagnostic Reagents for Markers of Herpes Virus Infection;
EU Reference Laboratories for the Detection or Quantification of Markers of Bacterial Pathogen Infection with Extracorporeal Diagnostic Reagents;
EU Reference Laboratories for the Detection or Quantification of Extracorporeal Diagnostic Reagents for Respiratory Virus Markers.
The regulation designates it as a directory of EU reference laboratories
Paul-Ehrlich-Institut (PEI) laboratory, Germany;
Instituto de Salud Carlos III, Spain;
Public Health Clinic, Sericio Madrile o de Salud, Spain;
Hospital Gregorio Mara ón - Spain;
Hospital Universitario La Paz - Spain;
Hospital Universitario Ramón y Cajal - Spain.
The European Union has published a Common Specification (CS) guideline
General specification of devices for the detection of blood group antigens in the ABO, RH, Kell, Duffy, and Kidd blood group systems.
General Specification for Devices for the Detection or Quantification of Markers of Human Immunodeficiency Virus (HIV) Infection.
General Specification for Devices for the Detection or Quantification of Markers of Human T-Cell Lymphotropic Virus (HTLV) Infection.
General Specification for Devices for the Detection or Quantification of Markers of Hepatitis C Virus (HCV) Infection.
General Specification for Devices for the Detection or Quantification of Markers of Hepatitis B Virus (HBV) Infection.
General Specification for Devices for the Detection or Quantification of Markers of Hepatitis D Virus (HDV) Infection.
General Specification for Devices for the Detection or Quantification of Markers of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection.
General specification for devices for the detection of markers of Treponema pallidum infection.
Welcome to click on the above fan me to pay attention to [Jiushun Medical Equipment Technical Service] medical equipment knowledge is not lost!