Reference Labs for Class D IVDs Selected by EC

Nearly 18 months after seeking applications for reference laboratories to cover eight categories of class D in vitro devices, the European Commission has adopted a regulation designating the labs to cover:

• Hepatitis and retroviruses
• Herpes viruses
• Bacterial agents
• Respiratory viruses that cause life-threatening diseases

The regulation requires manufacturers to adapt their current processes to conformity assessment for compliance with EU reference laboratory testing principles. The conformity assessment process is expected to begin in October 2024.

Arboviruses, hemorrhagic fever and other biosafety level 4 viruses, parasites and blood grouping are the remaining four categories.

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