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.

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.

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