[Webcast]: Meeting the UDI requirements for Medical Devices and In-vitro Devices by GS1 and SoftGroup

Description

 

The deadline for the introduction of serialization for medical devices and in vitro diagnostic devices is approaching. However, their implementation raises certain questions and challenges for manufacturers, importers, and authorized distributors.

We are pleased to invite you to listen to the webcast for the upcoming regulations.

 

Available after:  26th  November 2020

 

Language: English

 

Key topics

 

  • Medical Devices Regulation (MDR) (2017/745/EU)
  • In Vitro Medical Device Regulation (IVDR) (2017/746/EU)
  • UDI Carriers – Barcode Format & Human-readable information
  • Medical Devices & In Vitro Devices classifications & implementation dates
  • European database on medical devices (EUDAMED) – overview, timelines, modules, and registration
  • Differences in requirements EU MDR vs US FDA

 

Lecturers

 

GS1 Bulgaria

GS1 is an international not-for-profit association with Member Organisations in over 112 countries. GS1 is dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors. The GS1 system of standards is the most widely used supply chain standards system in the world.

 

SoftGroup

SoftGroup is a software company that provides all-in-one traceability technology to the pharmaceutical industry worldwide. In the last 16 years of experience, the company has been recognized as a reliable serialization and aggregation solution provider from Big Pharma Leaders with many production lines to small Marketing Authorization Holders (MAHs) with no real production.

 

Webcast fee

 

The regular participation fee is 95 EUR per person, paid by Bank transfer.

 

 

Request the webcast

 

You can listen to the last updates after  requesting the webcast here

 

 

Keywords:

Serialization solution, Medical Devices Regulation in Europe, UDI-DI, EUDAMED, UDI_DI, UDI-PI, EUDAMED Actors, EUDAMED Registation, EUDAMED fees

 

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