🇨🇿 Overview of new developments in the regulation of MDs and IVDs - autumn 2025

The event is held in Czech language only!

In recent years, the regulation of medical devices and IVDs has undergone one of the most significant changes in decades. A revision of the MDR and IVDR is in preparation, new implementing regulations and MDCG methodological documents are being created, and the launch of the Eudamed database is approaching. New topics are also coming to the fore, such as cybersecurity in medical technologies, mandatory electronic prescriptions, and the impact of the European Deforestation Regulation. These changes are complemented by developments in pricing and reimbursement regulation and the categorization of medical devices, which have a direct impact on the economic strategies of both suppliers and healthcare providers.

It is becoming increasingly difficult for the management of MedTech companies and healthcare facilities to keep track of developments and flexibly implement new requirements in practice. That is why we have prepared a regular six-monthly webinar that offers a comprehensive and understandable overview of key legislative changes over the past half-year and a look at what the near future will bring. Participants will receive clearly structured information on what requires immediate attention, what changes are on the horizon, and what trends will shape the market and regulatory environment in the coming years.

Who the webinar is for:

• managers of manufacturers

• executives of importers and distributors

• middle management of hospitals

• staff of notified bodies

• staff of the Ministry of Health, the Ministry of Medical Affairs and the State Institute of Health Care

• persons working in the healthcare sector with a focus on medical devices

Lecturers:

• Jakub Král

• Aneta Dostálová

Content:

• revision of MDR and IVDR

• new implementing regulation on electronic IFU

• preparations for the launch of the Eudamed database

• new MDCG documents

• regulation (EU) 2023/1115 on deforestation

• public consultation on the law on medical devices and IVDs

• new law on cybersecurity

• mandatory ePrescription of medical devices

• news in reimbursement regulation – VZP and EMDN codes

• law on the categorization of medical devices

• amendment to the law on public health insurance

• price regulation of medical devices and IVDs – expected changes

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 Legal s.r.o., advokátní kancelář

• ID: 17491681, VAT: CZ17491681

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