🇨🇿 UDI and medical device labeling – news and practical experience

The event is held in Czech language only!

The online seminar is intended for manufacturers, distributors, and importers actively addressing the issue of medical device labeling. The seminar will offer a brief introduction to the general rules for labeling according to the requirements of the MDR and IVDR, as well as the EN ISO 15223-1 and EN 20417 standards. It will then focus on practical experience with the labeling of medical devices and an updated interpretation of certain requirements, particularly in the area of UDI. The seminar will also include a demonstration of UDI code creation software, recommendations for selecting printing technology parameters, and warnings about basic problems in code creation as well as the labeling of medical devices in general.

Who the webinar is for:

• manufacturers' regulatory specialists

• manufacturers' quality department staff

• manufacturers' technical staff responsible for printing labels

• distributors' and importers' regulatory specialists

• anyone working in healthcare who wants to broaden their horizons on this issue

  
  

Speakers:

• Magdalena Folkmanová

• Sidónia Molitorisová

• Guest – Jakub Cihlář (GS1)

Content:

• basics of medical device labeling

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

• requirements for legibility and durability of labeling

• basic requirements for UDI

• practical experience with UDI implementation

• exceptions to UDI rules

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

• basic requirements for selecting software for labeling and UDI creation

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

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

Further information:

• participants will have the opportunity to ask questions during the webinar

• 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 organized by:

• Porta Medica s.r.o.

  IČ: 03301931, DIČ: CZ03301931

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