🇨🇿 Vigilance in Practice – MDR/IVDR Rules and the Vigilance Module in EUDAMED
Properly setting up a vigilance system is a key process for ensuring that devices are placed on the market safely. Our webinar will provide you with a practical guide to MDR requirements, assessing incidents, and preparing step by step for the rollout of the vigilance module in EUDAMED.
Date
10 Dec 2026, 09:30 – 12:00
Online: Cisco Webex
About
The event is held in Czech language only!
This webinar on medical device vigilance is intended primarily for manufacturers, but also for distributors and importers. During the webinar, we will explain the basic vigilance terminology and processes in accordance with the MDR and IVDR and provide a detailed breakdown of the individual steps in the vigilance process based on best practices set out in the available MDCG guidance documents. We will also clarify the roles of distributors and importers in this process and the specific vigilance obligations that apply to them.
The second part of the webinar will be dedicated to the EUDAMED Vigilance and Post-Market Surveillance module. We will also present the expected timeline for the mandatory use of the module, as the declaration of its full functionality is expected in the near future. We will demonstrate how this electronic system will replace the existing reporting procedures, focus on the practical requirements for working in the module, and explain how vigilance reports can be identified and linked to specific registered devices.
The webinar will also include practical demonstrations of user interaction with the database interface and the performance of individual vigilance activities. We will walk through the entire lifecycle of a Manufacturer Incident Report (MIR), the centralized management of field safety corrective actions (FSCAs), including field safety notices (FSNs), and the submission of trend reports and periodic safety update reports (PSURs).
Who the webinar is for:
Staff of medical device manufacturers, importers, and distributors, particularly those working in the following roles:
regulatory affairs specialist
quality manager
person responsible for regulatory compliance (PRRC)
product manager
head of logistics
Lecturers:
Ing. Jakub Musil
Mgr. Martin Kárász
Content:
Legal basis of the vigilance system under the MDR and IVDR
Key terminology: serious incident, field safety corrective action (FSCA), trend reporting
Individual steps in the vigilance process (in particular, MDCG 2023-3 guidance)
Roles of distributors and importers
Expected timeline for the mandatory use of the EUDAMED Vigilance and Post-Market Surveillance module
Lifecycle of a Manufacturer Incident Report (MIR)
Practical use of the database and submission of reports
Management of vigilance documents directly in the database
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