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.

In order to simplify the administrative procedure for radiation applications subject to notification in accordance with Section 32 of the Radiation Protection Act (StrlSchG) in the context of clinical investigations pursuant to the Medicinal Products Act (AMG) or Regulation (EU) 2017/745 on medical devices (MDR), a change of responsibility will take effect on 1 July 2025.

Incident report

The BfArM launches a new version of the DMIDS module "Clinical investigations and performance studies" on July 1, 2025.

Notification of interruptions or discontinuation of the supply of a medical device

MDR and IVDR conceptualize EUDAMED as the central platform for the European exchange of information and data on medical devices.