Pursuant to the Regulations (EU) 2017/745 and (EU) 2017/746 (MDR and IVDR) as well as German national regulations a favourable opinion of the competent ethics committee and an approval of or notification to the competent authority is required in order to perform a clinical investigation / performance study for medical devices.

With its barrier-free (according to BITV, German Barrier-free Information Technology Ordinance), graphical user interface the German Medical Devices Information and Database System (Deutsches Medizinprodukte-Informations-und Datenbanksystem, DMIDS) contributes to the market surveillance of medical devices in Germany.

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.