🇨🇿 Comprehensive Overview of New Developments in Medical Device and In Vitro Diagnostic Regulation – Fall 2026

The event is held in Czech language only!

The field of medical device and in vitro diagnostic (IVD) regulation has been undergoing permanent changes in recent years, with a significant impact on the day-to-day operations of medical device suppliers, notified bodies, and healthcare providers, particularly hospitals. The legislative process for the extensive revision of the MDR and IVDR continues; new implementing regulations from the European Commission and methodological guidelines from the MDCG are being adopted; and the deadlines for submitting the required device data to the European Eudamed database will expire in the fall of 2026.

At the same time, cross-cutting European legislation is gaining increasing importance, particularly in the areas of cybersecurity, packaging and packaging waste, batteries, artificial intelligence, and other related regulations. Among the most significant developments this year are the introduction of mandatory electronic prescriptions for medical devices, significant progress in the preparation of the new "ZUM" reimbursement regulation, and the implementation of national legislation addressing shortages and supply disruptions of medical devices. It is also necessary to prepare for a comprehensive amendment to the legal regulations governing advertising. These changes will affect not only the obligations of manufacturers, importers, and distributors of medical devices, but also those of all types of healthcare providers—from outpatient clinics and dispensaries to large healthcare facilities.

It is becoming increasingly difficult for the leadership of companies operating in the medical device and IVD sectors, as well as for the management of healthcare providers, to keep track of the rapidly evolving regulatory requirements and effectively implement them in their day-to-day operations. For this very reason, we have prepared a regular semi-annual webinar that provides a comprehensive and clear summary of the most important legislative changes from the past six months, as well as an outlook on expected regulatory developments in the coming period. Participants will receive systematically organized information on topics requiring immediate attention, upcoming changes, and long-term trends that will shape the medical device market and the regulatory environment in the coming years.

Who is the webinar for:

• Executives at medical device and IVD manufacturers

• Executives at medical device and IVD importers and distributors

• Middle management at hospitals

• Staff at notified bodies

• Staff at the Ministry of Health, the National Institute of Public Health, the State Institute for Drug Control, and health insurance companies

• Individuals working in the healthcare sector with ties to the medical device or IVD fields

Speakers:

• JUDr. Jakub Král, Ph.D.

• Mgr. Martin Kárász

Content:

• Revisions to the MDR and IVDR

• Digital Omnibus and changes to the AI Act

• Mandatory use of the Eudamed database and the end of the transition period

• National regulations on device shortages and supply disruptions

• Further development of the ISZP

• Revision of the national Medical Devices and IVD Act

• Mandatory ePrescription – evaluation and follow-up changes

• Updates on prescription medical devices reimbursement regulations

• Legislative anchoring of the "ZUM"

• Advertising regulations

• Cybersecurity

• Packaging and waste regulations

• Battery Regulation

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