【EXPERT Q&A】Which in vitro diagnostic medical devices are required to be assessed by EURLs for export to the EU, and what are the specific reference laboratories involved?

January 25, 2024  Source: drugdu 63

Drugdu.com expert's response:

 
For the export of in vitro diagnostic (IVD) medical devices to the European Union, certain types of products may require assessment or testing by designated European Union Reference Laboratories (EURLs). These reference laboratories mainly focus on high-risk in vitro diagnostic medical devices, particularly those closely related to public health.

The types of IVD products typically evaluated by EURLs include:

  • Infectious Disease Diagnostic Devices: For detecting major infectious diseases such as HIV, Hepatitis B, and Hepatitis C.
  • Blood Screening Devices: Used for blood safety testing, such as devices for detecting pathogens in blood.
  • High-Risk Cancer Biomarker Diagnostic Devices: For detecting high-risk biomarkers of certain types of cancer.
  • Genetic Disease Diagnostic Devices: For detecting specific genetic diseases or susceptibilities.

The EU designated reference laboratories include:

  • ECDC (European Centre for Disease Prevention and Control): Responsible for the detection and control of infectious diseases.
  • EURL for Blood Borne Infections: Specifically responsible for the detection of blood-borne infections.
  • Other Specialized Laboratories: Possibly established for specific diseases or types of tests.

The purpose of these reference laboratories is to ensure that in vitro diagnostic medical devices meet the EU's safety and performance standards before they are marketed. They provide services such as testing, validation, and technical support to help ensure the quality and reliability of IVD products on the market.

If your IVD product requires evaluation or testing by these reference laboratories, it is advisable to work with a professional compliance consultant to ensure that your product meets all relevant EU regulations and standards. Additionally, it is important to stay updated with changes in EU regulations to ensure ongoing compliance.

 
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By editor
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