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EU laboratories

EU laboratory regulations

The European Commission, in line with Regulation (EU) 2017/746, embarked on an extensive selection process for EU reference laboratories, launching a call for applications across eight scopes in July 2022. This call prompted Member States to submit designations by March 31, 2023, followed by meticulous evaluations conducted by a dedicated selection board under the Commission's auspices.

During the evaluation, the selection board meticulously considered various criteria established for EU reference laboratories, meticulously outlined in Article 100(4) of Regulation (EU) 2017/746, alongside the comprehensive Articles 1 to 9 of Implementing Regulation (EU) 2022/944. These laboratories, upon designation, would undertake vital roles, including performance verification and batch testing for class D devices, meticulously aligned with the stipulations set out in the respective annexes of Regulation (EU) 2017/746.

The successful designation of these laboratories marks a significant milestone, forming the bedrock of a network essential for coordination, harmonization, and standardization of testing methodologies as mandated by Article 100(5) of Regulation (EU) 2017/746. However, the Commission acknowledges the necessity for a grace period, allowing the newly appointed EU reference laboratories, manufacturers, and notified bodies sufficient time to adapt their operational processes before assuming their critical roles in conformity assessments.

Therefore, the application of these designations will be deferred to a later date, facilitating a smooth transition and effective collaboration within this crucial regulatory framework.

EU laboratories
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