On 12th December, Team-NB published a press release titled: “Important update on the Implementation of Class D oversight by EURLs: Endorsement of Multi Services Agreement template.”
Team-NB Advances Class D Device Oversight
Notified Bodies made significant progress in implementing performance and batch verification for Class D devices, including standardizing oversight processes and endorsing a Multi Services Agreement (MSA) template with European Reference Laboratories (EURLs). This document will facilitate the establishment of agreements and workflows between Notified Bodies and EURLs, supporting the implementation of EU Regulations. It aims to address the challenges associated with overseeing Class D devices certified under the IVDR.
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The previous press release from October for the transition of this implementation can be found here: PressRelease-ClassD-20241001.pdf
Link for this press release 12th December can be found here: Press-Release-EURLs-TransitionToOperations-20241212.pdf
Team-NB’s press release highlights the availability of safe and compliant in Class D devices used in testing in Europe. For guidance on navigating evolving regulations, contact us today.
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