🇨🇿 Mandatory use of the EUDAMED database: a practical guide to deadlines and obligations

The event is held in Czech language only!

After long delays, the EUDAMED database will become mandatory for all relevant economic operators as of May 28, 2026. The use and filling of the EUDAMED database are certainly associated with a number of significant benefits for the entire medical device and IVD sector, nevertheless, the fulfillment of registration obligations in the short transition period is also accompanied by a significant administrative burden on the part of some economic operators. The aim of our webinar will primarily be to provide a clear overview of all legislative obligations and the deadlines for their fulfillment.

The presentation will be structured as a comprehensive guide that will show, from a practical point of view, how to perform the individual mandatory activities directly in the database environment. We will focus in particular on the obligations associated with the registration of economic operators, with a significant part devoted to the registration of medical devices for all types and the specific obligations of importers. Last but not least, we will focus on methods of reducing the administrative burden, such as bulk data uploads to the database and avoiding potential errors during the registration process.

Who the webinar is for:

• Regulatory specialists of Manufacturers and Systems and procedure pack Producers,

• Employees from Quality and PRRC departments,

• Regulatory specialists of Importers and Distributors,

• Healthcare providers and other users who want to draw data from the EUDAMED database for their own work.

Lecturers:

• Ing. Jakub Musil

• Ing. Terézia Vedral

Content:

• EUDAMED and its legislative basis in the MDR and IVDR texts

• Practical overview of obligations for all Economic Operators (Actors)

• Orientation deadlines by which obligations must be fulfilled

• Relationship between the EUDAMED database and national databases (ISZP, RZPRO)

• The process of registering an Economic Operator (the "Actor registration" module).

• The process of linking to non-EU Manufacturers for Importers.

• The process of registering medical devices (the "UDI/Devices registration" module).

• Bulk uploading of data to the EUDAMED database – practical advice and tips.

  
  

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