- Designation of EU Reference Laboratories: The regulation, dated December 6, 2023, designates specific laboratories in the European Union as EU reference laboratories for in vitro diagnostic medical devices. This designation is in accordance with Regulation (EU) 2017/746 and involves a thorough selection process based on criteria outlined in the regulation.
- Annual Review Process: The Commission initiated a call for applications in July 2022, evaluating applications submitted by Member States by March 31, 2023. The selection board considered criteria for EU reference laboratories, and successful laboratories are designated for specific devices or hazards related to devices.
- Deferred Application of Designation: The application of the designation of EU reference laboratories for the tasks outlined in Article 100(2) of Regulation (EU) 2017/746 is deferred until October 1, 2024. This delay allows the designated laboratories time to form a network and harmonize their working methods. The newly designated laboratories will only perform tasks for devices with formal applications for conformity assessment lodged after October 1, 2024, ensuring legal certainty and predictability in conformity assessment procedures.
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