A new guidance for sponsors has been published: Clinical investigation/performance study (KP/LS) in accordance with MDR, IVDR and MPDG

Medical devices and in vitro diagnostic devices as well as information on the PRRC have to be notified via DMIDS until 28 May 2026.

Incident report

Reporting Recalls

Further developing the safety and supply of medical devices, strengthening coordination and governance at EU level - The European medical device authorities have published a joint statement on the MDR and IVDR.