Artificial Intelligence: Council & Parliament agree to simplify and streamline rules
As Team-NB , we’d like to remind that AI Omnibus has no impact on the format of the conformity assessment of MDAI. An integrated procedure is and remains being foreseen as per [...]
TEAM NB Position Paper on Clinical Evaluation Based on Non-Clinical Data
Team-NB members adopted, at the unanimity of the presents, a paper aimed to outline the approach taken by the NB when considering the acceptability of a manufacturer’s justification for relying on non-clinical [...]
TEAM NB Position Paper on BPG for the Submission of TD – V4
Team-NB members adopted, at the unanimity of the presents, the updated 4th version of the notified bodies BPG harmonized approach to clarify information to be submitted by the manufacturer in their technical [...]
MDR Clinical Training for Manufacturers
TEAM-NB set up a training for manufacturers dedicated to clinical aspects. What’s new: The training has been extended from half a day to a full day. It is planned on May 28th. [...]
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