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The European Commission has provided an update on the designation of EU reference labs. Reference labs are intended for high-risk medical devices and should be a part of the conformity assessment process. There are currently no reference labs designated for the IVDR.

In July 2022, the European Commission opened applications to become a reference lab, specifically under 8 categories:

  • Hepatitis and retroviruses
  • Herpesviruses
  • Bacterial agents
  • Arboviruses
  • Respiratory viruses that cause life-threatening diseases
  • Haemorrhagic fever and other biosafety level 4 viruses
  • Parasites
  • Blood grouping

These applications were submitted to Member States who conducted a review then passed applications onto the European Commission by March 2023.

A total of 8 applications have been received by the European Commission. These applications are under review to establish whether the labs satisfy the criteria necessary, and to determine capacity. The combined capacity of all compliant labs must cover the expected volume of requests in order for designation to occur.

There is not sufficient capacity to cover Haemorrhagic fever and other biosafety level 4 viruses, so no reference lab will be designated for this category.

This review is expected to be completed by Q3 2023. 

Notified bodies can continue to certify class D IVDs in the absence of reference labs.