On the way to the perfectly identifiable bed with the UDI
The MDR has entered into force - but the UDI product number still needs time.
The EU Medical Devices Regulation (MDR) came into force on 26 May. All current products of the Stiegelmeyer-Group have already been MDR-compliant since May 2020. However, one subject about which we receive a lot of questions can only be implemented in the future: the Unique Device Identification (UDI) on the type plate.
This product identification number is particularly interesting, because with its help one should be able to find information about the respective medical device in a European database in the future. But this database, called EUDAMED, is far from finished.
At least the EU Commission has taken the first step and put a module online with which industry players like Stiegelmeyer and Burmeier can register with EUDAMED. This module will first be reviewed by the member states – in Germany by the Federal Ministry of Health. Once the ministry has approved the module, registration will become mandatory for industry players. Dealers are exempt from this.
This step will be followed by many others. The launch of the EUDAMED database for class I medical devices, which also includes medical beds, is currently planned for May 2025. Until then, our beds will already be marked with part of the final UDI number: the "Basic UDI DI". You will find this number, for example, in the EU Declaration of Conformity for your product, which you can request from your Stiegelmeyer or Burmeier representative, or you can find it in every instruction manual.
This means that our products fully comply with the requirements of the MDR and are a secure investment in the future, because they will of course enjoy grandfather status even if the gradual development of the MDR entails further changes such as the UDI in the coming years.