European UDI Regulation on Labelling and Registration of Medical Devices

European UDI Regulation on Labelling and Registration of Medical Devices

European UDI Regulation on Labelling and Registration of Medical Devices

With the adoption of the new EU Medical Device Regulation (MDR) by the European Parliament on April 5, 2017, the European UDI Regulation on the Labelling and Registration of Medical Devices now also comes into force.

According to the Official Journal of the European Union, the new Medical Devices Regulation, which is described in Article 24, is binding for all medical device manufacturers who sell their products in Europe after a three-year transition period starting April 25, 2020.

In future, our UDI SAP Add-On will support the administration of EUDAMED – European UDI Data – in addition to the master data administration of FDA UDI data.

Ismail Demiralp