software solutions for UDI

Questions? - Answers!

• What is UDI used for?
  In healthcare, the patients safety has the highes priority. The beasis for this is the consistent identification of medical instruments starting from the manufacturer through retailers and the hospital to the patient. With UDI, medical instruments are labeld with a gobally unique identification. This leads to a complete transparency in the entire supply chain.
  
  The term "UDI-Compliant" indicates, that a medical device is uniquely labeled.
• Who requires UDI?
  For anyone who wants to export their products to the American market, sooner or later the UDI policy will be mandatory. Also in the EU it is planned to require the UDI policy for medical products. Therefore, it is reasonable that manufacturers have their medical devices marked for all countries with UDI-compliant code to take advantage of UDI immediately rather than to local legal requirements.
• What does UDI consist of?
  UDI describes a complete system: UDI consists of a unique code on the product or the packaging. In addition, UDI includes storing the data of medical products in a central database.
• What has to be labeled?
  Medical devices of risk class I, II and III have to be provided with a globaly unique, machine-readable code (for example a bar code). This code is the key to a database that contains detailed information to the product. The same code is also applied to the smalles packaging size.
• What does the UDI-Label consists of?
  The marked label must be based on certain standards. Accredited by the FRA are the standards HIBC, GS1 and ISBT. No matter what standard you choose: The label must always consist of a Device Identifier (DI) and a Product Identifier (PI). The DI contains the manufacturer or labeler. The PI is dnynamic and can contain multiple data to the product like the expiration date, the serial number or the date of production. Through the worldwide network GUDID manufacturers can submit the productinformation to the UDI-Database of the FDA.
  With the Schilling marking lasers the standards thar are accredited by the FDA can be complied easily. The special standards HIBC and GS1 can be marked with the Schilling marking lasers.