UDI - Unique Device Identification

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01

Course description

A comprehensive course on the UDI (Unique Device Identification) system applied to medical devices, integrating ANVISA, FDA (GUDID), European MDR (EUDAMED) requirements and IMDRF recommendations, focusing on practical implementation, issuing entity selection and compliant labelling.

02

Course objective

Enable participants to implement the UDI system in their organisation, selecting the appropriate issuing entity, structuring data for official databases (GUDID, EUDAMED, ANVISA) and adapting labelling and packaging to applicable legislation.

03

Course programme

16h of in-depth learning
  1. 01

    UDI system fundamentals and objectives

  2. 02

    Structure: DI (Device Identifier) and PI (Production Identifier)

  3. 03

    Accredited issuing entities (GS1, HIBCC, ICCBBA, IFA)

  4. 04

    FDA and GUDID requirements

  5. 05

    MDR and EUDAMED requirements

  6. 06

    UDI implementation in Brazil (ANVISA)

  7. 07

    Labelling, AIDC and implementation good practice

04

Who can attend?

  • Regulatory Affairs, Quality, Packaging/Labelling, Logistics and IT professionals, Technical Managers and consultants involved in UDI implementation across multiple jurisdictions.