Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will become fully applicable on May 26, 2022. In this context, we would like to draw the reader’s attention to… Read More
IVD medical devices after the IVDR date of application
Month: March 2022
New guidance for notified bodies of MDD/ AIMDD legacy device certificates and IVDR class D devices
The European Commission has issued new guidance documents that concern the activities of notified bodies under Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR). MDCG 2022-3 provides clarification on verification… Read More