A label with an hourglass, a factory, an umbrella, a thermometer, a barcode and a qr code on it, symbolizing UDI-compliant labelling of medical devices

March 26: UDI compliant labeling of medical devices

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The Importance of UDI

The labeling of medical devices and in vitro diagnostic medical devices serves to facilitate traceability and the availability of standardized information. In case of a malfunction traceability helps to identify products quickly and reliably.

In the future, new European legal framework for medical devices and new regulations in the US market will oblige manufacturers to introduce a system of unique device identification (UDI) for medical devices. Many manufacturers are now faced with the question of how these regulatory requirements can be met and how they can create added value for the company.

Benefit from our expert knowledge

At our workshop at March 26, 2019 two experts will explain the new legal requirements and show you how to successfully implement a traceability system as a project in your company.

Program

13:30Registration
14:00Welcome and Introduction
Dr. Thorsten Prinz, VDE
14:15Legal Requirements for UDI – Identification and Traceability of Medical Devices
Dr. Boris Handorn, Lawyer and Partner
Simmons & Simmons LLP, Munich
  • Preparing for UDI: Market players and identification within the supply chain
  • What is the roadmap for the implementation of the MDR requirements?
  • Which data must be entered into the UDI database by the manufacturer?
  • What contractual adaptations are required of suppliers and sales partners?
14:45Discussion
15:00Coffee Break
15:30UDI From the Point of View of a Global Medical Device Manufacturer
Michael Ankele, Division Manager Materials Management, Purchasing and Logistics
Erbe Elektromedizin GmbH, Tübingen
  • What are the differences between the requirements in the USA and in Europe?
  • What are the components of a UDI system?
  • Which areas and processes of the manufacturer are affected by UDI?
  • Master data management: Internal data becomes external data
  • What consequences does the introduction of UDI have for the manufacturer in the event of product changes?
  • What comes next? UDI and RFID?
16:00Discussion
16:15Networking
17:00End of the event

Program subject to change without notice. Last updated: February 2019

The number of participants is limited.

The language of the workshop is German. However, English is available upon request.

Venue

Haus am Dom
Domplatz 3
60311 Frankfurt am Main

Participation

The participation fee is 150,00 EUR for regulator participants. VDE members pay a reduced fee of 135,00 EUR. Participation and refreshments during breaks are included, but not the costs for overnight stay or travel to and from the event.
Cancellation conditions: up to 14 days before the date of the event free of charge, thereafter 100 % of the participation fee as cancellation fee.

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