🇨🇿 Amendment Regulation on MDR and IVDR

The event is held in Czech language only!

We would like to invite you to an online seminar designed for manufacturers and importers of general medical devices and in vitro diagnostic medical devices, as well as especially for hospital representatives. During the webinar we will present in detail a major legislative change resulting in the phased early launch of the European Medical Device Database Eudamed, the mandatory advance notification of expected outages of important devices/IVDs on the market and the conditional extension of the transition periods for legacy IVDs.

Speakers:

• Jakub Král
• Aneta Dostálová

Content:

•  current state of implementation of MDR and IVDR
•  development of the certification of the ZP and IVD
•  practical experience with Regulation (EU) 2023/607
•  reasons for the adoption of the amending regulation
•  the current status and near future of the Eudamed database
•  UDI records 
•  revision of hospital purchasing catalogues
•  mandatory reporting of outages of PPs and IVDs on the market
•  extension of the transition periods for legacy IVDs

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