Common goal: Ensuring safe care with innovative medical devices

The implementation of the European regulations on medical devices (MDR) and in-vitro diagnostics (IVDR) was the topic of a workshop organised by the authorities responsible for medical devices in the EU on 10th of July 2024. Together with representatives of the European Commission, current priorities, challenges and possible solutions for successful implementation were identified.

"Our common goal and priority is to ensure that patients in the EU continue to have access to safe care and innovative medical devices," said BfArM President Prof Karl Broich. "The rapid and successful implementation of the relevant European regulations is an important prerequisite here. We stand ready to support the Commission and work together to ensure that the regulatory system achieves its objectives and is applied efficiently in practice."

The results of this workshop form the basis for further work together with the European Commission. At the end of the meeting, the heads of the authorities signed an open letter to the European Commission, calling on it to prioritise the implementation of the EU Medical Devices Regulations.

Medical device competent authority statement on the status of the EU regulatory system