🇨🇿 Obligations of importers and distributors of medical devices - good practice and news
A webinar for importers and distributors who want to clarify what obligations currently apply to them. It will focus on duties under the EU MDR and IVDR regulations and good storage practices. Issues will be illustrated with examples from practice and part of the webinar will be dedicated to news.
Date
01 Apr 2025, 09:30 – 12:00
Online: Cisco Webex
About
The event is held in Czech language only!
The development of medical device legislation has been turbulent in recent years. Not sure what obligations actually apply to you and where to look for them? Are you confused by the new transitional provisions for legacy devices and don't know what documents to request from your suppliers? Or do you just want to refresh your existing knowledge of medical device regulation and learn "more" than what you can read in the text of the legislation? If so, you've come to the right place. The online seminar will focus on the obligations under the European MDR and IVDR regulations, reporting obligations and good storage practice. It will be practical, not just theoretical. Participants will learn, for example, how to prepare for an inspection by the SCD, what documents to request from suppliers in connection with the extension of the transition period for legacy devices, or how to translate instructions and repackage or relabel medical devices, and much more.
Who the webinar is for:
employees of importers and distributors of medical devices, mainly in the positions of:
regulatory specialist
quality manager
product manager
marketing specialist
Speakers:
Veronika Moravová
Aneta Dostálová
Content:
brief overview of legislation and legislative news
extension of the transition period for legacy devices
basic obligations of distributors under the MDR/IVDR
translations of instructions for use, repackaging and relabelling of devices
reporting obligations in ISZP and RZPRO, news in Eudamed
preparation for an inspection by the SCL - good storage practice, internal SOPs, quality agreements
role of importers and distributors in vigilance
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 Legal s.r.o., advokátní kancelář
IČ: 17491681, DIČ: CZ17491681
registered office at Opletalova 1525/39, 110 00, Prague 1 - Nové Město