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🇨🇿 UDI and labelling of medical devices - news and practical experience

The webinar is intended for manufacturers and suppliers who are actively addressing the issue of medical device labelling. The aim of the webinar is not only to offer an overview of the basic labelling rules, but also to focus on updated requirements, especially in the area of UDI labelling.

🇨🇿 UDI and labelling of medical devices - news and practical experience
🇨🇿 UDI and labelling of medical devices - news and practical experience

Date

06 Mar 2025, 09:30 – 12:00

Online: Cisco Webex

About

The event is held in Czech language only!


The online seminar is intended for manufacturers, distributors and importers actively dealing with medical device labelling issues. The seminar will provide a brief introduction to the general rules for labelling according to the requirements of the MDR and IVDR as well as EN ISO 15223-1 and EN ISO 20417. It will then focus on practical experiences with medical device labelling and an updated interpretation of some of the requirements, particularly in the area of UDI. The seminar will also include a demonstration of software-based UDI code creation, recommendations on the selection of print technology parameters, and highlighting basic issues in code creation and medical device labelling in general.


Who the webinar is for:

  • to the manufacturer's regulatory specialists

  • personnel from the manufacturer's quality department

  • the manufacturer's technology staff responsible for printing the markings

  • regulatory specialists of distributors, importers

  • all those who work in the healthcare sector and want to broaden their horizons in this field


Lecturers:

  • Barbora Charvátová

  • Magdalena Folkmanová


Guest:

  • Jakub Cihlář (GS1)


Content:

  • basics of medical device labelling according to MDR or IVDR

  • the role of EN ISO 15223-1 and EN ISO 20417

  • requirements for legibility and durability of labelling

  • basic requirements for UDI

  • practical experience of UDI implementation

  • exceptions to the UDI rules

  • the most pressing areas of UDI and current interpretation of the requirements

  • basic requirements for the selection of software for the creation of labels and UDIs

  • practical demonstration of UDI code creation in software (GS1)

  • code quality requirements, including UDI and EAN 13 (GS1)


Additional information:

  • During the webinar, participants will have the opportunity to ask questions

  • each participant will receive a certificate of participation

  • a PDF presentation will be sent to all participants


Participation fee:

  • 3.900 CZK excluding VAT

  • 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant


Webinar hosted by:

  • Porta Medica

  • ID: 03301931, VAT: CZ03301931

  • registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město

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