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MEDICA
November 18-21, 2019
Dusseldorf, Germany
Booth #10B05





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MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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Requirement for UDI labeling - more than a sequence of (alpha) numeric characters


With the new Medical Device Regulation (MDR), an unambiguous Unique Device Identification (UDI) code is required. The UDI is a labeling system for medical devices currently being introduced worldwide, which was first created by the "International Medical Device Regulators Forum" " IMDRF and then implemented by the "Food and Drug Administration" FDA for the improvement of patient safety. It serves the purpose of complete identification of medical devices, from the manufacturer and specialist retailers / hospitals, through to the user.

Thus, recalls and market surveillance of medical devices, as well as the documentation of serious incidents, should be simplified. The UDI records product data and manufacturing reference numbers, as well as production and shelf life data.

The new EU Regulations (MDR, IVDR) regulate the mandatory introduction of the UDI system. The required implementation time of the UDI labeling depends on the risk class of the medical device. After the MDR has become effective, a transition period of one year applies for class III devices. Class IIa and IIb devices have to be UDI compliant within three years, and for devices of the lowest risk class I, the law allows up to five years for the implementation.

MDSS Consulting GmbH guides you safely through the jungle of the new UDI directive and answers your specific questions such as:
  • Which devices or components must be labeled with UDI?
  • Which data must be consolidated in the company to be provided to the data banks? 
  • Where do I obtain my UDI? 
  • Where must I place the UDI? 
  • Which procedures must be updated in the QM system? 
  • Where must the UDI data be processed?

We will define with you a procedure – how to implement and apply the UDI in an MDR compliant manner. In doing so, we focus on the profitability and on a risk-based approach according to your device class and take into consideration the requirements of the health systems of the Member States. Feel free to contact us – we will be happy to support you!


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