EU Reference Laboratories

The European Commission has adopted two implementing acts in order to lay the groundwork in setting up EU Reference Laboratories for high-risk IVDs. These acts seem to be rather robust and very specific, meaning that laboratories wishing to apply as a Reference Laboratory for the testing of such devices should be able to understand the requirements reasonably easily.

Commission Implementing Regulation (EU) 2022/944 indicates the criteria to be met by EU Reference Laboratories, including:

• Staff requirements.
• Equipment and reference materials.
• International standards and best practices.
• Administrative organisation and structure.
• Outsourcing.
• Accreditation.

On the other hand, Commission Implementing Regulation (EU) 2022/945 indicates a specific structure with which laboratories can build their fees.