Labeling of medical devices with UDI according to MDR / IVDR

The new EU regulations for medical devices and IVDs have been in force since May 26, 2021 (MDR) and May 26, 2022 (IVDR). With these regulations, the introduction and implementation of unique device identification (UDI) for medical devices is now also mandatory in the EU. The main focus is on improving patient safety. The UDI requirements are also an important part of the conformity assessment for obtaining the CE marking.
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In order to be able to offer you first-hand information, we are organizing this seminar in cooperation with GS1 Austria, an official UDI allocation body in Europe since 2019.

The seminar contents

  • MDR – Requirements for UDI:
    • Overview UDI
    • UDI interfaces (quality management, production, other business processes)
    • UDI as part of EUDAMED
    • Registration of products
    • Registration of economic operators
    • Requirements and responsibilities, especially for OEM manufacturers, private label manufacturers
  • The GS1 System – What are the GS1 standards and their role?
    • GS1 identifications: GLN, GMN, GTIN, NTIN, SSCC, GRAI
    • GS1 barcodes: EAN/UPC, GS1-128, GS1 DataMatrix, GS1 QR Code
    • GS1 data exchange: GDSN, EDI
  • Steps for the successful implementation of UDI
    • UDI award rules
    • UDI labeling rules
    • Barcode quality
    • Barcode check
    • Master data management
    • Master data exchange

Your trainer

Poppy Abeto Kiesse, MSc., Business Development Manager Healthcare bei GS 1 Austria GmbH

Information about our trainers

Costs

1 day in-house training: Euro 3.790,- (excl. VAT) for max. 10 participants; incl. seminar documents and certificate of attendance, plus travel expenses.

Book now:

Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491