Training

MDR Suite #5: EUDAMED & UDI

November 25, 2020

Date: 25th of November 2020

Time: 15:00h - 17:00h CET 

Location: Virtual

Language: English

Costs: € 395,-

Package deal (12 sessions): € 3750.-  *

* Team Members with Different Roles & Responsibilities? No problem!
We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package
.

Introduction

Device identification and traceability system based on UDI and submission of comprehensive product information to EUDAMED are two major additions in the MDR and IVDR. The regulatory requirements for UDI aim to ensure positive identification of a medical device, improve accuracy and completeness of adverse event reporting, enhance management of recalls, eliminate use of counterfeit products and reduce medical errors.

Implementation of UDI and adoption of EUDAMED will require substantial investments by healthcare stakeholders. Solutions need to account for capabilities of producing compliant coding symbiology and barcode scanning to auto-capture the information. IT systems must allow for UDI information to be shared, maintained and utilized for electronic patient records, adverse event reporting, product recalls and other applications related identification and traceability.

Learning Objectives

  • Introduction to UDI
  • Basic UDI-DI
  • Labelling
  • Introduction to EUDAMED
  • Actor registration
  • Device & UDI registration
  • QMS Impact

Trainer:

Agnieszka Schreiber
Post date: September 28, 2020
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