🇨🇿 Practical guide to the EUDAMED database: obligations, deadlines, registration

The event is held in Czech language only!

After long delays, the EUDAMED database is becoming an obligation for many medical device handlers. Unfortunately, along with the real outlines of this tool comes the realisation of the knowledge and technical pitfalls and the overall time-consuming processes involved in validation and data entry. The online seminar is intended for manufacturers, procedure pack producer, importers or distributors of medical devices, but also for other entities that are actively addressing the issue of meeting EU legislative requirements in connection with the launch of the EUDAMED database. The webinar will start with a complete overview of the requirements arising from the MDR and IVDR together with the current timetable for the implementation of the individual modules of the database. The seminar will summarise the upcoming obligations for all affected economic operators, with particular emphasis on registration obligations. The webinar will review the registration process itself for all types of devices (including legacy devices) from a practical perspective. We will follow up with the possibilities offered to users by bulk data upload. We will present an automated tool for bulk upload that makes the registration process for MDs and IVDs much easier. Last but not least, we will discuss how to use the EUDAMED database efficiently and what benefits its active use in the future offers for all entities active in the healthcare sector.

Who the webinar is for:

• regulatory specialists of manufacturers and procedure pack producers

• quality managers of manufacturers and procedure pack producers

• regulatory specialists of distributors and importers

• all those working in the healthcare sector who want up-to-date information on the practical use of the EUDAMED database

Lecturers:

• Jakub Musil

• Aleš Martinovský

Content:

• overview of legislative requirements related to the EUDAMED database

• timetable and key dates for the implementation of the EUDAMED

• obligations of economic operators in the EUDAMED

• the process of registering an economic operator ("Actor registration" module)

• registration process for MDs and IVDs (module “UDI/Devices registration”)

• obligations and registration process for legacy devices

• bulk upload of data to the EUDAMED - practical hints and tips

• introduction of the automated tool

• possibilities and efficient work in the EUDAMED environment

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

• ID: 03301931, VAT: CZ03301931

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