🇨🇿 UDI and Labeling in Practice: Why Does It Affect You, and How Can You Avoid Failing to Comply?

The event is held in Czech language only!

This online seminar is intended for manufacturers, distributors, and importers who are actively addressing the issue of medical device labeling. In the introduction, we will provide a clear overview of the general labeling rules in accordance with the requirements of the MDR and the key standards EN ISO 15223-1 and EN ISO 20417.

We will then move beyond the theory and focus on what matters most—practical experience and an up-to-date interpretation of more complex requirements, particularly regarding the specifics of UDI. You can look forward to analyses of specific real-world examples.

We’ll also discuss recommendations for selecting the right software, present procedures for verifying the quality of the resulting labeling, and highlight the most common pitfalls that lead to errors when creating codes in practice.

Who the webinar is for:

• Regulatory specialists at manufacturers

• Quality department staff at manufacturers

• Manufacturing technicians responsible for printing labeling

• Regulatory specialists at distributors and importers

• Anyone working in the healthcare sector who wishes to broaden their knowledge of this topic

Lecturers:

• Ing. Magdalena Folkmanová

• Mgr. Sidónia Molitorisová

Content:

• Basics of medical device labeling

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

• Requirements for the legibility and durability of labeling

• Basic requirements for the UDI

• Practical tips for creating a UDI

• Exceptions to the UDI rules

• The most pressing UDI issues and current interpretations of the requirements

• Overview of changes from the proposed revision of the MDR

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 s.r.o.

  ID: 03301931, VAT: CZ03301931

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