🇨🇿 Overview of new developments in the regulation of MDs and IVDs - spring 2026

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 transformations in decades. The legislative process for a major revision of the MDR and IVDR has already begun, new implementing regulations and MDCG guidance documents are being developed, and the deadline for mandatory use of the Eudamed database is approaching. Cross-cutting legislation is coming to the forefront, including cybersecurity, packaging and waste regulations, the AI Act, and more. New developments this year include mandatory electronic prescribing of medical devices and the preparation of future reimbursement regulations of extra reported medical devices (ZUM). Consequently, the obligations of not only manufacturers, importers, and distributors of medical devices but also healthcare providers - ranging from small ambulances and dispensaries to large hospitals - are undergoing fundamental changes.

It is becoming increasingly challenging for the management of MedTech companies and healthcare facilities to stay on top of developments while flexibly implementing new requirements into practice. That is why we have prepared a regular semi-annual webinar that offers a comprehensive and clear overview of key legislative changes over the past six months, as well as a look at what the near future holds. Participants will receive clearly structured information on what requires immediate attention, what changes are on the horizon, and which 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:

• mandatory ePrescription on medical devices

• revision of the MDR and IVDR

• mandatory transition to EUDAMED, overlap with ISZP

• revision of the Medical Devices Act and IVD

• updates on pricing and reimbursement regulation

• VZP methodology for conducting cost-effectiveness analyses

• legislative anchoring of ZUM

• advertising regulation

• cybersecurity

• packaging and waste regulation

• omnibus bill on the AI Act

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