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Class D – press release Notified Bodies

To: Class D WG and Regulatory Affairs IVD Committee Dear members, Regarding Class D devices under EURLs, please note to the recent press release from the TEAM-NB (Notified Bodies’ association) accessible via the following link. The press release confirms Notified Bodies’ positive reception of the newly revised MDCG 2021-4 guidance and provides reassurance that the batch testing process will continue…
Ben Kemp
October 9, 2024