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 […]
<h1 class="entry-title">Category: eIFU</h1>
EU eIFU Regulation: Broader Than Many Think
March 22, 2022 EU eIFU Regulation: Broader Than Many Think Everyone seems to know that Europe’s Regulation (EU) 2021/2026 covers requirements for when eIFU are provided instead of paper IFU. But did you know that the Commission also demands a certain level of conformity with that Regulation also for when eIFU is provided in […]