EUDAMED

A bar code in the background, a pole with direction signs, UDI-DI and UDI-PI written on it, symbolizing the UDI system, enhancing traceability . A bar code in the background, a pole with direction signs, UDI-DI and UDI-PI written on it, symbolizing the UDI system, enhancing traceability .
2019/01/11 - Regulatory Affairs - Updated: 2019/11/28 - Thorsten Prinz and Michael Ankele

Traceability of Medical Devices

Traceability plays a key role in increasing the safety of medical devices. Now, Unique Device Identification (UDI) also applies in Europe.

A paper with the letters MDD, the D is crossed out and an R added to make it MDR. It symbolises the transition. A paper with the letters MDD, the D is crossed out and an R added to make it MDR. It symbolises the transition.

Transition Period of the EU MDR: What Dates Manufacturers Need to Know

The new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period.