🇨🇿 Obligations of Importers and Distributors, Including the Basics of Advertising Regulation

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 about 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, good storage practice and the basics of advertising regulation. 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, what is involved in translating instructions and repackaging or relabeling medical devices, what to look out for when preparing marketing materials, and much more.

The webinar is cross-sectional and aims to present the most important things that concern you as importers or distributors "in a nutshell". For those interested in further deepening their knowledge, we have also prepared follow-up seminars that go into more detail on specific topics such as advertising regulation, ISZP, vigilance or the MDR and IVDR amendment regulations. More information on these training events can be found in the Diary section of our website above.

Speakers:

• Veronika Moravová
• Aneta Dostálová

Content:

• a brief overview of the legislation
• extension of the transition period for legacy devices
• basic obligations of distributors under the MDR/IVDR
• good storage practices
• the role of importers and distributors in vigilance
• translations of instructions for use, repackaging and relabelling of devices
• reporting obligations
• preparation for an inspection by the SCD
• preparation of standard operating procedures
• quality agreements
• basics of advertising regulation

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