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eIFU MDD & EU MDR Notified Body is Required (as applicable)

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eIFU MDD & EU MDR Notified Body is Required (as applicable)

Posted by Kevin Randall In CE Mark, eIFU, EU MDD, EU MDR 0 comment

April 6, 2023

eIFU MDD & EU MDR Notified Body is Required (as applicable)

 

Both Regulation (EU) 207/2012 (the eIFU regulation for the MDD) and Regulation (EU) 2021/2226 (the eIFU regulation for the EU MDR) require that conformity with those regulations be reviewed by a European notified body where applicable (i.e., for those device classes/types requiring notified body involvement for conformity assessment).

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