EU Commission Sets Criteria for Reference Labs under the IVDR

The Commission of the European Union (EU) has recently detailed the criteria and tasks applicable to EU reference laboratories (EURLs) specializing in the assessment of high-risk in vitro diagnostic medical devices (IVDs) under EU Regulation (EU) 2017/746 (otherwise known as the IVDR).

Published in the Official Journal of the European Union, Commission Implementing Regulation (EU) 2022/944 sets forth detailed criteria applicable to EURLs in the areas of staffing, equipment, standards and best practices, administrative organization and structure, and confidentiality.

The Implementing Regulation then goes on to delineate the specific tasks to be undertaken by EURLs, including verification of product performance and compliance with common specifications, sample or batch testing, and establishing common rules of procedure.

In a separate Implementing Regulation, (EU) 2022/945, the Commission identifies specific costs that can be included in the fee structure applied by EURLs and requires them to establish rules for calculating the fees to be paid.

Read the Commission’s Implementing Regulation on the criteria and tasks applicable to EURLs.

Read the text of the Implement Regulation on EURL fees.

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